Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

17 January 2024 (*)

(Biocidal products – Treated articles – Active substance carbendazim – Regulation (EU) No 528/2012 – Directive 98/8/EC – Implementing Regulation (EU) 2021/348 – Approval – Duration of approval – Principle of non-discrimination – Legitimate expectations – Error of law – Manifest error of assessment – Precautionary principle – Transitional rules)

In Case T‑297/21,

Troy Chemical Company BV, established at Delft (Netherlands),

Troy Corp., established at Florham Park, New Jersey (United States),

represented by D. Abrahams and Z. Romata, lawyers,

applicants,

v

European Commission, represented by M. Farley and R. Lindenthal, acting as Agents,

defendant,

supported by

French Republic, represented by G. Bain, acting as Agent,

and by

European Chemicals Agency (ECHA), represented by M. Heikkilä, C. Buchanan and T. Zbihlej, acting as Agents,

interveners,

THE GENERAL COURT (Ninth Chamber),

composed of L. Truchot, President, M. Sampol Pucurull (Rapporteur) and T. Perišin, Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure,

further to the hearing on 8 February 2023,

gives the following

Judgment

1        By their action under Article 263 TFEU, the applicants, Troy Chemical Company BV and Troy Corp., seek annulment of Commission Implementing Regulation (EU) 2021/348 of 25 February 2021 approving carbendazim as an existing active substance for use in biocidal products of product types 7 and 10 (OJ 2021 L 68, p. 174) (‘the contested regulation’).

I.      Background to the dispute and facts subsequent to the lodging of the action

2        Troy Chemical Company is a company incorporated in the Netherlands that places biocidal products, including film protectants and masonry protectants containing carbendazim, on the EU market. Troy Corp., which is incorporated under the laws of the State of Delaware (United States), is the holding company of Troy Chemical Company.

3        It follows from recital 3 of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1) and recital 1 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1) (together, ‘the Biocidal Products Regulation’), that biocidal products are necessary to control organisms harmful to human or animal health and organisms that damage natural or manufactured materials and that such products may pose various risks to humans, animals and the environment, due to their inherent properties and associated uses.

4        As an existing active substance in biocidal products, carbendazim is a systematic fungicide with a protective action that inhibits the development of germ tubes, the formation of appressoria and the growth of mycelia.

5        After being notified as an existing active substance, carbendazim was included, in 2003, in the review programme provided for in Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1). More recently, carbendazim was included in Annex II to Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation No 528/2012 (OJ 2014 L 294, p. 1), which contains the list of existing active substances to be evaluated with a view to their possible approval for use in biocidal products (‘the work programme’).

6        On 31 October 2008, Troy Chemical Company submitted an application for approval of carbendazim as an active substance to the evaluating competent authority, in the present case the Federal Republic of Germany (‘the evaluating competent authority’), for product type 7, namely film protectants (‘TP 7’), and product type 10, namely masonry protectants (‘TP 10’), as described in Annex V to Directive 98/8, which correspond, respectively, to TP 7 and TP 10 as described in Annex V to Regulation No 528/2012.

7        On 2 August 2013, the evaluating competent authority submitted the initial version of the evaluation report with its conclusions to the European Commission.

8        In November 2019, in its latest version of the evaluation report, the evaluating competent authority expressed its concerns about the effects, which it described as unacceptable, of carbendazim on the environment during the outdoor use of paints (TP 7) and plasters (TP 10) containing that substance.

9        On 10 December 2019, in accordance with Article 7(2) of Delegated Regulation No 1062/2014, the opinions of the Biocidal Products Committee of the European Chemicals Agency (ECHA), established by Article 75 of Regulation No 528/2012 (‘the BPC’), were adopted taking into account the conclusions of the evaluating competent authority.

10      In those opinions, the BPC proposed approving carbendazim and including it in the list of approved active substances on the basis of the requirements laid down in Article 5 of Directive 98/8, provided that certain specifications and conditions relating to the authorisation of biocidal products and treated articles were met. It also concluded that carbendazim met the criteria for classification as a persistent and toxic substance under the provisions of Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1). In addition, the BPC considered in its opinions that the outdoor use of paints and plasters treated with or incorporating carbendazim posed unacceptable risks to surface waters and sediments during their lifetime and that no appropriate risk mitigation measures could be identified to avoid the release of carbendazim into the sewage system during the life of those treated articles when used outdoors.

11      On 23 September 2020, at a meeting of the Standing Committee on Biocidal Products established under Article 28 of Directive 98/8 (‘the standing committee’), the question was discussed whether the contested draft regulation should provide for restrictions on the use of biocidal products and treated articles containing carbendazim. Following that meeting, the Commission announced that it would present a new version of the contested draft regulation, which would include such restrictions.

12      On 5 November 2020, the Commission’s services held a meeting with Troy Chemical Company about the amendments to the contested draft regulation.

13      On 23 November 2020, Troy Chemical Company sent the Commission its comments on the European Parliament’s draft resolution on the contested draft regulation.

14      On 26 November 2020, the Parliament adopted a resolution on the contested draft regulation in which it considered that the draft regulation was not compatible with the aim and content of Directive 98/8 and that it was not proportionate in view of the unacceptable risks that carbendazim was likely to pose to human health and the environment.

15      On 10 December 2020, at the meeting of the standing committee, the Commission presented the revised version of the contested draft regulation, including certain restrictions to take account of the risks previously identified. That draft was made available to the Member States and discussed.

16      On 5 February 2021, the standing committee delivered a positive opinion on the revised version of the contested draft regulation.

17      On 25 February 2021, the Commission adopted the contested regulation by which it approved, subject to certain specifications and conditions (‘the specific conditions’), carbendazim as an active substance for use in biocidal products falling within TP 7 and TP 10.

18      By email of 18 March 2021, Troy Chemical Company sent the Commission two requests for access to documents relating to the procedure leading to the adoption of the contested regulation on the basis of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43).

19      By Decision C(2021) 5968 final of 5 August 2021, the Commission refused Troy Chemical Company access to certain parts of four documents relating to the first of the applications referred to in paragraph 18 above.

20      By application lodged at the Registry of the General Court on 15 October 2021, Troy Chemical Company brought an action under Article 263 TFEU for annulment of Decision C(2021) 5968 final, registered as Case T‑662/21. The action was dismissed by judgment of 26 July 2023, Troy Chemical Company v Commission (T‑662/21, not published, EU:T:2023:442).

II.    Procedure and forms of order sought

21      By application lodged at the General Court Registry on 21 May 2021, the applicants brought the present action.

22      By separate document lodged at the General Court Registry on 18 June 2021, the applicants brought an application for interim measures seeking a stay of execution of the contested regulation.

23      By order of 25 October 2021, Troy Chemical Company and Troy v Commission (T‑297/21 R, not published, EU:T:2021:733), the President of the General Court dismissed the application for interim measures referred to in paragraph 22 above.

24      By document lodged at the General Court Registry on 8 November 2021, the applicants requested the Court to adopt measures of inquiry seeking the production of a number of documents, in accordance with Article 88 and Article 91(b) of the Rules of Procedure of the General Court.

25      By order of 30 January 2023, the General Court ordered the Commission, on the basis of the first paragraph of Article 24 of the Statute of the Court of Justice of the European Union and Article 91(b), Article 92(3) and Article 103 of the Rules of Procedure, to produce the full version of the draft presentation for the decision on the application for approval of carbendazim for use in TP 7 and TP 10 attached to the email from the Directorate-General (DG) for Health and Food Safety to the Legal Service of the Commission of 17 November 2020 (‘the draft presentation’).

26      By decision of 9 March 2023, the General Court decided that the draft presentation was relevant to the decision in the present case and was not confidential. It was therefore communicated to the applicants and they were invited to comment on it.

27      The applicants claim that the Court should:

–        declare the application admissible and well founded;

–        annul the contested regulation;

–        order the Commission to pay the costs;

–        take such other or further measure as justice may require.

28      The Commission contends that the Court should:

–        dismiss the action as unfounded;

–        order the applicants to pay the costs.

29      ECHA contends that the Court should:

–        dismiss the action as unfounded;

–        order the applicants to pay the costs.

30      The French Republic submits that the Court should dismiss the action.

III. Law

A.      Admissibility

1.      Admissibility of the action

31      Under the fourth paragraph of Article 263 TFEU, any natural or legal person may bring an action against acts of direct and individual concern to that person.

32      Since the contested regulation is not addressed to the applicants, it must be determined whether it is of direct and individual concern to them.

33      In the first place, it is necessary to examine the situation of Troy Chemical Company.

34      First, the condition of direct effect requires that the measure at issue directly produce effects on the legal position of the individual and that it leave no discretion to those to whom that measure is addressed and who are responsible for implementing it, since the measure is of a purely automatic nature and arises solely from the legislation at issue without the application of any other intermediate rules (see judgments of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 33 and the case-law cited, and of 9 June 2021, Puma and Others v Commission, T‑781/16, not published, EU:T:2021:328, paragraph 46 and the case-law cited).

35      In the present case, the contested regulation approves carbendazim as an active substance in the context of the continuation of the work programme referred to in paragraph 5 above. Pursuant to Article 1 thereof, the approval of carbendazim for TP 7 and TP 10 is subject to certain specifications and conditions set out in the annex to that regulation. Thus, in so far as Troy Chemical Company ensures the placing on the market of biocidal products containing carbendazim, the contested regulation directly affects its legal position. Moreover, since the approval of carbendazim is subject to the specific conditions laid down in that regulation, the Member States have no discretion in that regard (see, to that effect, judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 55 and the case-law cited). Troy Chemical Company is therefore directly concerned by the contested regulation.

36      Secondly, as regards the condition of individual concern, it should be borne in mind that a person other than the addressee of an act can claim to be individually concerned within the meaning of the fourth paragraph of Article 263 TFEU only if that measure affects him or her by reason of certain qualities peculiar to him or her or by reason of a factual situation which distinguishes him or her from any other person and thereby individualises him or her in a way similar to that in which the addressee would be individualised (judgment of 15 July 1963, Plaumann v Commission, 25/62, EU:C:1963:17, p. 223).

37      The EU Courts have found on several occasions that the applicant for approval of an active substance, having submitted the dossier and having participated in the assessment procedure, was individually concerned both by an act authorising the active substance subject to conditions and by an act refusing authorisation (see, to that effect, judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 55 and the case-law cited).

38      In the present case, it is common ground, first, that Troy Chemical Company is the author of the application for approval of carbendazim submitted on 31 October 2008 under the work programme and, secondly, that it participated in the approval procedure for that substance, the stages of which have been noted in paragraphs 7 to 17 above. Moreover, as the Commission acknowledges, it was the only legal entity registered as a supplier of carbendazim-based biocidal products falling within TP 7 and TP 10 under Article 95(2) of Regulation No 528/2012. Troy Chemical Company is therefore individually concerned by the contested regulation.

39      It follows from the considerations set out in paragraphs 33 to 38 above that Troy Chemical Company is entitled to challenge the contested regulation, which is not disputed by the Commission.

40      In the second place, as regards Troy Corp., the Commission has doubts as to its standing to bring proceedings.

41      It is settled case-law that, for reasons of procedural economy, if the same implementing regulation is challenged by several applicants and it is established that one of them has standing to bring proceedings, there is no need to examine the standing of the other applicants to bring proceedings (see, to that effect, judgments of 24 March 1993, CIRFS and Others v Commission, C‑313/90, EU:C:1993:111, paragraph 31, and of 9 June 2011, Comitato ‘Venezia vuole vivere’ and Others v Commission, C‑71/09P, C‑73/09 P and C‑76/09 P, EU:C:2011:368, paragraphs 36 and 37).

42      Consequently, since Troy Chemical Company has standing to bring an action against the contested regulation, the present action must be declared admissible, without there being any need to examine Troy Corp.’s standing to bring the action.

2.      Admissibility of the fourth head of claim

43      It should be borne in mind that the subject matter of the dispute and the form of order sought by the appellant are two essential particulars which, in accordance with Article 21 of the Statute of the Court of Justice of the European Union and Article 76(d) and (e) of the Rules of Procedure, must appear in the application initiating proceedings.

44      It is also necessary to point out in that regard that, as is clear from settled case-law, any application initiating proceedings must state the subject matter of the dispute and a summary of the pleas in law, and that that statement must be sufficiently clear and precise to enable the defendant to prepare his or her defence and the EU Courts to exercise its review function. Similarly, the form of order sought in the application initiating proceedings must be worded unequivocally in order to prevent the court from ruling ultra petita or omitting to rule on a complaint (see order of 7 May 2013, TME v Commission, C‑418/12 P, not published, EU:C:2013:285, paragraph 33 and the case-law cited).

45      It suffices to note that the fourth head of claim, the wording of which is set out in paragraph 27 above, is of a general and imprecise nature, so that it does not satisfy the conditions laid down in Article 76(e) of the Rules of Procedure.

46      Consequently, the fourth head of claim must be declared inadmissible.

B.      The substance

47      In support of their action, the applicants formally put forward four pleas in law, alleging:

–        first, that the Commission erred in law, misused its powers, infringed the principle of the protection of legitimate expectations, infringed the principle of non-discrimination and committed a manifest error of assessment in setting the approval period for carbendazim at three years;

–        secondly, the manifest error of assessment and misuse of powers committed by the Commission in concluding that specific conditions were necessary to prohibit the use of biocidal products in paints and plasters intended for outdoor use;

–        thirdly, the manifest error of assessment and error of law committed by the Commission in concluding that specific conditions were necessary in order to prohibit the placing on the market of specific treated articles (namely paints and plasters treated with carbendazim or in which that substance had been incorporated) intended for outdoor use;

–        fourthly, the ‘manifest error of law and fact’ committed by the Commission in concluding that specific conditions were necessary for the labelling of paints and plasters treated with carbendazim or in which that substance had been incorporated, intended for outdoor use, to remind users that it was prohibited to use them outdoors.

48      As a preliminary point, it should be noted that, according to the case-law, the Court must interpret an applicant’s pleas in law by reference to their substance rather than their characterisation and thus characterise the pleas in law and the arguments in the application (see, to that effect, judgment of 5 September 2014, Éditions Odile Jacob v Commission, T‑471/11, EU:T:2014:739, paragraph 51; see also, to that effect, judgment of 10 February 2009, Deutsche Post and DHL International v Commission, T‑388/03, EU:T:2009:30, paragraph 54 and the case-law cited).

49      In those circumstances, in the interests of the sound administration of justice, the Court considers that the applicants must be regarded as raising, in essence, seven pleas in law, alleging:

–        first, an error of law in the application of the transitional rules laid down by Regulation No 528/2012;

–        secondly, infringement of the principle of the protection of legitimate expectations;

–        thirdly, infringement of the principle of non-discrimination;

–        fourthly, an error of law, a manifest error of assessment and misuse of powers as regards the fixing of the approval period for carbendazim;

–        fifthly, a manifest error of assessment, infringement of the principle of non-discrimination and misuse of powers resulting from the imposition of specific conditions prohibiting the use of certain biocidal products containing carbendazim for the treatment of paint and plaster intended for outdoor use;

–        sixthly, an error of law, a manifest error of assessment and misuse of powers resulting from the imposition of specific conditions applicable to the placing on the market of certain articles treated with carbendazim, or in which that substance is incorporated, and intended for outdoor use;

–        seventhly, an error of law arising from the specific conditions imposed on the labelling of paints and plasters treated with carbendazim, or in which that substance has been incorporated, and intended for outdoor use.

1.      Preliminary observations

50      It should be noted that Directive 98/8 aims to improve the free movement of biocidal products within the European Union, while guaranteeing a high level of protection for human and animal health and the environment. That objective is also pursued by Regulation No 528/2012, which repealed and replaced that directive. In that context, Regulation No 528/2012 relies on the precautionary principle in order to ensure that the manufacture and making available on the market of active substances and biocidal products do not give rise to harmful effects on human or animal health or unacceptable effects on the environment (see, to that effect, judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 111).

51      In order to pursue that objective effectively, and in view of the complex scientific assessments which the Commission must make when it carries out, in the context of the examination of applications for approval of active substances under Regulation No 528/2012, the assessment of the risks presented by the use of those substances, a broad discretion must be conferred on that institution (judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 112). That also applies to the risk management decisions which it must take pursuant to that regulation (see, by analogy, judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 92).

52      The exercise of that power is not, however, exempt from judicial review. In that regard, it is settled case-law that, in the context of that review, the EU Courts must verify compliance with the procedural rules, the material accuracy of the facts relied on by the Commission, the absence of a manifest error in the assessment of those facts or the absence of misuse of powers (see judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 93 and the case-law cited).

53      As regards the assessment by the EU Courts of the existence of a manifest error of assessment, it should be made clear that, in order to establish that the Commission committed such an error in examining complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that measure implausible. Subject to that examination of plausibility, it is not for the General Court to substitute its assessment of complex facts for that of the author of the measure (see, to that effect, judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 94 and the case-law cited).

54      Furthermore, it should be borne in mind that, in cases where an institution has a broad discretion, it is of fundamental importance to monitor compliance with the guarantees conferred by the EU legal order in administrative procedures. Those guarantees include, in particular, the obligation on the competent institution to examine carefully and impartially all the relevant facts of the case and to give sufficient reasons for its decision (see, to that effect, judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 114 and the case-law cited).

55      It has thus been held that carrying out a scientific risk assessment which is as exhaustive as possible on the basis of scientific opinions founded on the principles of excellence, transparency and independence constitutes an important procedural guarantee with a view to ensuring the scientific objectivity of measures and avoiding the taking of arbitrary measures (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 172).

56      It is in the light of those considerations that it is appropriate to examine the seven pleas in law put forward, in essence, by the applicants in support of their action.

2.      The first plea in law, alleging an error of law in the application of the transitional rules laid down in Regulation No 528/2012

57      The first plea relied on by the applicants is in two parts. The first relates to the erroneous application of conditions for approval which are not provided for by the transitional rules in Article 90(2) of Regulation No 528/2012 (‘the transitional rules’). The second part deals with the erroneous taking into account of the transitional period of access to national markets enjoyed by biocidal products containing carbendazim as a factor for determining the approval period for that substance.

(a)    The first plea in law, alleging misapplication of conditions for approval not provided for in the transitional rules

58      In essence, the applicants criticise the Commission for having applied the criteria laid down in Article 5 of Regulation No 528/2012 by taking into consideration, at the stage of approval of carbendazim, the classification of that substance as mutagenic category 1B and toxic for reproduction category 1B within the meaning of Regulation (EC) No 1272/2008 of the European Parliament and of the Council, of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1) (‘the inherent properties’). They point out that carbendazim is one of the existing active substances benefiting from the transitional rules, so that it is subject only to the substantive assessment conditions of Directive 98/8, to the exclusion of those provided for in Regulation No 528/2012. Therefore, by taking those inherent properties into account in order to determine the period of approval of carbendazim, the Commission, in the contested regulation, essentially applied Article 5 of Regulation No 528/2012 in breach of the transitional rules.

59      The Commission, supported by ECHA, contests the applicants’ argument.

60      The French Republic, intervening in support of the Commission, adds that all the elements characterising the profile of the active substance must be taken into account when determining the duration of its approval.

61      As a preliminary point, it is necessary to take note of the context in which the transitional rules were adopted, before determining whether, as the applicants submit, the Commission erred in law in applying them.

62      In that regard, first of all, it should be emphasised that Directive 98/8 established for the first time a regulatory framework for the authorisation and placing on the market of biocidal products, laying down as a condition a high level of protection for humans, animals and the environment. In particular, under that directive, Member States could only authorise the placing on the market of biocidal products if they contained active substances listed in Annex I, Annex IA or Annex IB to that directive.

63      In addition, under Article 16(2) of Directive 98/8, the Commission was to initiate a 10-year work programme for the systematic examination of all active substances already on the market on 14 May 2000. The aim of that work programme was to identify existing active substances and to determine which of them should be examined in that context with a view to their possible inclusion in Annex I, Annex IA or Annex IB to Directive 98/8.

64      The rules on the authorisation and placing on the market of biocidal products were subsequently adapted with the adoption of Regulation No 528/2012, which repealed and replaced Directive 98/8 with effect from 1 September 2013. That regulation lays down new rules governing, in particular, the establishment at EU level of a list of active substances that may be used in biocidal products.

65      In order to facilitate the transition from Directive 98/8 to Regulation No 528/2012, transitional rules were laid down in Articles 89 to 95 of that regulation concerning, in particular, the assessment of applications for approval of active substances and authorisation of biocidal products submitted before the application of that regulation.

66      Thus, first, the work programme referred to in paragraph 63 above was carried out by the Commission pursuant to Article 89(1) of Regulation No 528/2012.

67      Secondly, Article 90(2) of Regulation No 528/2012 provides that applications for the evaluation of active substances submitted for the purposes of Directive 98/8 for which Member States have not completed the evaluation in accordance with Article 11(2) of Directive 98/8 by 1 September 2013 are to be evaluated by the competent authorities in accordance with the provisions of that regulation.

68      It follows that active substances in respect of which the Member States completed the evaluation by 1 September 2013 must be evaluated in accordance with the provisions of Directive 98/8. In the present case, it is mainly a question of the substantive conditions laid down in Article 5(1) and Article 10 of that directive, the latter setting a maximum duration of 10 years for the initial approval period for any active substance.

69      Thus, the transitional rules exclude the application of the substantive conditions for approval provided for in Regulation No 528/2012 and, in particular, the application of the maximum duration of five years for the initial approval period in cases where the exclusion criteria provided for in Article 5 of that regulation are met.

70      In the present case, as indicated in paragraph 5 above, it should be noted that carbendazim was included in the work programme in 2003 by Regulation No 2032/2003. It is therefore one of the existing active substances within the meaning of Article 89(1) of Regulation No 528/2012.

71      Moreover, it is not disputed that the evaluating competent authority sent its assessment report to the Commission on 2 August 2013, that is to say, before the deadline referred to in paragraph 67 above.

72      As a result, only the substantive conditions for approval in Directive 98/8 were applicable to the Commission’s assessment of carbendazim, to the exclusion of those provided for in Regulation No 528/2012.

73      It is in the light of those factors that it must be determined whether, as the applicants maintain, the Commission erred in law in applying the transitional rules when adopting the contested regulation.

74      In the present case, the contested regulation was adopted on the basis of the third subparagraph of Article 89(1) of Regulation No 528/2012. Moreover, recital 9 recalls that the approval of carbendazim is subject to the substantive conditions of Directive 98/8.

75      Furthermore, it is apparent from the file sent to the Court that the transitional rules were taken into account at the various stages of the approval procedure for carbendazim. Thus, the BPC opinions of 10 December 2019 state that, while that active substance meets the exclusion criteria of Article 5(1)(b) and (c) of Regulation No 528/2012, the analysis of the derogations provided for in paragraph 2 of that article is nevertheless irrelevant to the approval decision. Similarly, both the minutes of the 68th meeting of the standing committee of 15 May 2020 and the presentation annexed to the minutes of the 69th meeting of that committee attest to the application of the transitional rules.

76      It follows that the substantive conditions of Directive 98/8 were applied for the purposes of the adoption of the contested regulation, in accordance with the transitional rules.

77      Such a conclusion cannot be called into question by the following two factors put forward by the applicants.

78      First, the applicants rely on the reference in recital 9 of the contested regulation to Article 5(2) of Regulation No 528/2012 in order to conclude that that provision applies in relation to the approval of carbendazim.

79      In the present case, recital 9 of the contested regulation states that the approval period for carbendazim should be three years so that the question whether the conditions set out in Article 5(2) of Regulation No 528/2012 can be met for that active substance can be examined as soon as possible at European Union level in the context of a possible renewal of the approval.

80      It suffices to note that recital 9 of the contested regulation refers only to the need for a future review of the conditions laid down in Article 5(2) of Regulation No 528/2012, which will therefore take place only at the stage of renewal of the approval of carbendazim.

81      Accordingly, it cannot be inferred from recital 9 of the contested regulation that Article 5(2) of Regulation No 528/2012 applies at the stage of approval of that active substance.

82      Secondly, the applicants consider that the Commission was wrong to take into account the inherent properties of carbendazim in order to justify an approval period shorter than that provided for in Article 10(1) of Directive 98/8.

83      In that regard, it should admittedly be emphasised that the inherent properties of an active substance constitute a legal assessment criterion in the context of the approval procedure for an active substance under Regulation No 528/2012.

84      However, it should also be noted that the inherent properties of an active substance constitute, more generally, relevant characteristics linked to the toxicological profile of an active substance and, as such, represent a relevant factual element in the assessment of that active substance, irrespective of the application of the transitional rules.

85      Thus, it is important to emphasise that the inherent properties of active substances were already taken into account in Directive 98/8. Recital 3 of Directive 98/8 states that biocidal products can pose various risks to humans, animals and the environment because of their inherent properties and associated uses.

86      Furthermore, although Directive 98/8 did not contain a provision similar to Article 5(1) of Regulation No 528/2012, it nevertheless made a distinction between active substances according to the degree of risk presented by the biocidal products in which they were incorporated, as is apparent, in particular, from the third subparagraph of Article 10(1) of that directive.

87      It follows that, having regard to the broad discretion conferred on the Commission and referred to in paragraph 51 above, the application of the substantive conditions of Directive 98/8 by virtue of the transitional rules does not prevent it from taking into account all the relevant factual elements in order to determine the approval period for an active substance. Those factors include, in particular, the classification of the active substance as mutagenic category 1B and toxic for reproduction category 1B within the meaning of Regulation No 1272/2008, as set out in the assessment report of the evaluating competent authority.

88      Consequently, the assessment of the risk profile of carbendazim under Directive 98/8 requires account to be taken of its inherent properties, in so far as this is a relevant characteristic, in factual terms, linked to the toxicological profile of carbendazim.

89      It was therefore without committing an error of law that the Commission took into account, in recitals 8 and 9 of the contested regulation, the inherent properties of carbendazim in order to justify a reduced approval period in relation to the maximum period of 10 years laid down by Article 10(1) of Directive 98/8, without, however, basing the determination of that period on Regulation No 528/2012.

90      It follows that the first part of the first plea in law must be rejected.

(b)    The second part, alleging that the transitional period of access to national markets was incorrectly taken into account

91      The second part of the first plea is based on two complaints, the first alleging breach of the transitional rules and the second alleging misuse of powers.

(1)    The first complaint, alleging breach of the transitional rules

92      The applicants consider that the Commission erred in law by taking into account, in setting the approval period for carbendazim, the duration of the transitional period of access to the national markets enjoyed by biocidal products containing that active substance. As an active substance included in the work programme, access to the market for those biocidal products was permitted pending an approval decision by the Commission. According to the applicants, that mere derogating access cannot constitute a legitimate consideration justifying the reduction of the approval period for carbendazim. Moreover, the duration of that derogating access was the result of significant delays in the work programme, which are not specific to carbendazim.

93      The Commission, supported by ECHA and the French Republic, contests all of the applicants’ arguments.

94      It should be borne in mind that, under the transitional rules, carbendazim had to be approved on the basis of the substantive conditions for approval laid down in Directive 98/8 (see paragraphs 61 to 76 above). To that end, Article 10 of Directive 98/8 requires, inter alia, verification as to whether biocidal products containing an active substance may be expected to fulfil the conditions laid down in Article 5(1)(b) to (d) of that directive.

95      It must therefore be determined whether the provisions referred to in paragraph 94 above authorised the Commission to take account of the transitional period of access to the national markets of biocidal products containing carbendazim when calculating the approval period for that substance.

96      In that regard, it should be borne in mind that the interpretation of a provision of EU law requires account to be taken not only of its terms, but also of the context in which it is set and of the general scheme, objectives and purpose pursued by the act of which it forms part (see judgment of 4 March 2021, Agrimotion, C‑912/19, EU:C:2021:173, paragraph 21 and the case-law cited).

97      In the first place, it should be noted that neither the wording of Article 90(2) of Regulation No 528/2012 nor that of Article 10 of Directive 98/8 refers to the duration of the transitional period of access to national markets for the purposes of determining the approval period for an existing active substance.

98      Accordingly, without allowing any definitive conclusion to be drawn, it follows from a literal interpretation of those provisions that they do not formally prohibit the Commission from taking into account the duration of such a transitional period when calculating the approval period for an active substance.

99      In the second place, the applicable provisions must therefore be interpreted teleologically and contextually.

100    First of all, as is apparent from the factors set out in paragraph 50 above, Directive 98/8 and Regulation No 528/2012 share the same objective as regards the regulation of biocidal products and their active substances, namely to improve the free movement of biocidal products within the European Union while ensuring a high level of protection for human and animal health and the environment.

101    Next, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities.

102    Finally, it should be recalled that the objective of the transitional period of access to national markets from which certain biocidal products benefited, first under Article 16 of Directive 98/8 and then under Article 89 of Regulation No 528/2012 is, as is clear from recital 7 of that regulation, to facilitate the implementation of the work programme while avoiding depriving biocidal products containing existing active substances of access to national markets.

103    It follows that the establishment of such a transitional period was intended to achieve a balance between, first, the objective of protecting human and animal health and the environment and, secondly, that of preserving the functioning of the internal market by maintaining derogating market access for certain biocidal products during the implementation of the work programme.

104    It follows that one of the objectives pursued by the transitional period of access to national markets was to ensure a high level of protection of human, animal and environmental health, as set out in paragraph 100 above.

105    In the present case, it is clear that the work programme has been significantly delayed, necessitating two extensions to its term, first to 14 May 2014 and then to 31 December 2024.

106    Therefore, as the Commission points out, carbendazim and biocidal products containing that substance enjoyed transitional access to the national markets for a longer period than that initially provided for by the EU legislature, notwithstanding the risks which that substance posed to human, animal and environmental health, as recalled in paragraphs 58 and 87 above.

107    In those circumstances, the Commission could legitimately consider, in view of the wide margin of discretion available to it in the matter, that it was necessary to set the approval period for carbendazim at three years in order to bring the work programme to an early close and thus ensure compliance with the objectives set out in paragraph 100 above.

108    Accordingly, it does not appear that taking account of the duration of the transitional period of access to national markets in order to determine the period of approval of carbendazim is contrary to the transitional rules. Accordingly, the first complaint must be rejected.

(2)    The second complaint, alleging misuse of powers

109    The applicants submit that the Commission misused its powers in so far as taking account of the transitional period of access to national markets was, in reality, intended to penalise them for their participation in the work programme.

110    The Commission, supported by ECHA and the French Republic, contests the applicants’ arguments.

111    In that regard, it should be borne in mind that, according to settled case-law, an act is vitiated by misuse of powers only if it appears, on the basis of objective, relevant and corroborative evidence, to have been taken exclusively or at least decisively for purposes other than those for which the power in question was conferred (see, to that effect, judgment of 10 May 2005, Italy v Commission, C‑400/99, EU:C:2005:275, paragraph 38 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 334 and the case-law cited).

112    There is nothing to suggest that the Commission misused its powers in the present case.

113    The applicants do not provide any objective, relevant and consistent evidence on the basis of which it could be inferred that the contested regulation was adopted exclusively, or at least decisively, for purposes other than those for which the power in question was conferred on the Commission. In particular, as established above, the taking into account of the transitional period of access to national markets pursued the objective of guaranteeing the high level of protection of human and animal health and of the environment enshrined in the rules on biocidal products. It follows that the second complaint must be rejected.

114    It follows from all of the foregoing that, by taking account of the duration of the transitional period of access to the national markets in determining the period of approval of carbendazim, the Commission committed neither an error of law in the application of the transitional rules nor a misuse of powers.

115    In those circumstances, the second part of the first plea must be rejected, as must the first plea in law in its entirety.

3.      The second plea in law, alleging breach of the principle of the protection of legitimate expectations

116    The applicants consider that the approval period of three years laid down by the contested regulation infringes the principle of the protection of legitimate expectations in that it is shorter than the usual period of five years expressly provided for in the note of the Commission's expert group on the principles for taking decisions on the approval of active substances in the context of Regulation No 528/2012 (‘the principles note’) and applicable to existing active substances. That document would have created a legitimate expectation in the applicants’ minds as to the approval period applicable in the present case.

117    Moreover, that legitimate expectation would have been reinforced by the Commission’s practice of granting five-year periods for the approval of certain active substances in equivalent circumstances, in particular cholecalciferol, hexaflumuron, cyproconazole and MBM, although two exceptions exist, namely flufenoxuron and formaldehyde.

118    The Commission, supported by ECHA and the French Republic, contests all of the applicants’ arguments.

119    As a preliminary point, it should be noted that the right to rely on the principle of the protection of legitimate expectations, which is one of the fundamental principles of the European Union, presupposes the fulfilment of three cumulative conditions. First, precise, unconditional and consistent assurances, emanating from authorised and reliable sources, must have been provided to the interested party by the administration. Secondly, those assurances must be such as to give rise to a legitimate expectation in the mind of the person to whom they are addressed. Thirdly, the assurances given must comply with the applicable standards (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 109 and the case-law cited).

120    Thus, it must be assessed whether the Commission’s principles note and decision-making practice constituted precise, unconditional and consistent assurances emanating from authorised and reliable sources which could have created a legitimate expectation in the applicants’ minds that the approval period for carbendazim would be set at five years.

121    In the first place, with regard to the principles note, first, it should be noted that it was drawn up by a group of Commission experts from the Member States’ national competent authorities for biocidal products, the Commission services and industry stakeholders.

122    Secondly, the purpose of the principles note is, in particular, to explain the conditions for applying the transitional rules to the existing active substances included in the work programme.

123    To that end, the principles note refers to the Commission’s existing practice of authorising active substances for a maximum of 10 years and active substances meeting the exclusion criteria set out in Article 5 of Regulation No 528/2012 for a maximum of 5 years.

124    Thus, even assuming that precise, unconditional and consistent assurances had been provided by the principles note as regards the calculation of the approval period for active substances meeting the exclusion criteria within the meaning of Regulation No 528/2012, it must be noted that it refers only to maximum, and not minimum, periods, so that the applicants could not draw any conclusion from it as to the existence of an automatic approval period of five years for an active substance such as carbendazim.

125    Consequently, the applicants fail to show that any assurances were given to them by the Commission concerning the specific examination of carbendazim which could have given rise to a legitimate expectation in their minds.

126    Since the first of the three cumulative conditions referred to in paragraph 119 above is not satisfied, no breach of the principle of the protection of legitimate expectations can be established as regards the content of the principles note, without it being necessary to examine the other conditions.

127    In the second place, it is important to consider whether, as the applicants maintain, the Commission’s previous decision-making practice gave rise to a legitimate expectation in their minds as to the duration of the approval of carbendazim.

128    It should be borne in mind that the legality of a measure must be assessed in the light of the rules of law and, in particular, the provisions of the applicable regulation, and not on the basis of the Commission’s alleged previous decision-making practice (see, to that effect, judgment of 14 July 2021, Interpipe Niko Tube and Interpipe Nizhnedneprovsky Tube Rolling Plant v Commission, T‑716/19, EU:T:2021:457, paragraph 116 and the case-law cited).

129    Moreover, where a prudent and circumspect economic operator is in a position to foresee the adoption of an EU measure likely to affect his or her interests, he or she cannot rely on the benefit of the principle of the protection of legitimate expectations when that measure is adopted (see judgment of 23 January 2019, Deza v ECHA, C‑419/17 P, EU:C:2019:52, paragraph 71 and the case-law cited).

130    In particular, economic operators are not justified in placing their legitimate expectations in the maintenance of an existing situation which may be altered in the context of the discretion of the institutions of the European Union (see judgment of 7 October 2015, Accorinti and Others v ECB, T‑79/13, EU:T:2015:756, paragraph 76 and the case-law cited).

131    The Commission’s decision-making practice is liable to change in the light of changing circumstances or the development of its analysis (see judgment of 18 May 2022, Canon v Commission, T‑609/19, EU:T:2022:299, paragraph 395 (not published and the case-law cited)).

132    In the present case, it should be noted that the fixing of the approval period for an active substance subject to the transitional rules falls within the limits of the discretion granted to the Commission by the rules on biocidal products.

133    Accordingly, the Commission was entitled to fix the appropriate duration of the approval period within the limit of the 10-year period provided for by Article 10 of Directive 98/8, the application of which was maintained by the transitional rules.

134    It follows that the applicants could not acquire a legitimate expectation that the Commission would not depart from the duration previously fixed for other active substances such as cholecalciferol, hexaflumuron, cyproconazole or MBM. Moreover, the applicants acknowledge that the Commission’s decision-making practice in this area was not consistent, in so far as a three-year approval period had already been set for flufenoxuron, under Directive 98/8, and for formaldehyde, under the transitional rules.

135    Consequently, the applicants are wrong to rely on a breach of the principle of the protection of legitimate expectations.

136    In the light of the foregoing, the second plea in law must be rejected as unfounded.

4.      The third plea in law, alleging breach of the principle of non-discrimination

137    The applicants consider that the approval period set by the contested regulation for carbendazim constitutes discriminatory treatment in comparison with that applied by the Commission to other active substances in a substantially identical situation, without that difference in treatment being objectively justified. In their view, that discrimination is apparent principally when the approval period for propiconazole is compared with that for carbendazim, but also with that for other similar active substances.

138    The Commission, supported by ECHA and the French Republic, contests the applicants’ arguments.

139    It follows from settled case-law that the principle of equal treatment or non-discrimination requires that comparable situations should not be treated differently and that different situations should not be treated in the same way, unless such treatment is objectively justified (see judgment of 16 November 2022, Sciessent v Commission, T‑122/20 and T‑123/20, EU:T:2022:712, paragraph 121 and the case-law cited). The comparable nature of different situations is assessed having regard to all the factors which characterise them. Those factors must, in particular, be determined and assessed in the light of the object and purpose of the measure making the distinction in question. Account must also be taken of the principles and objectives of the field to which that measure relates (see, to that effect, judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 312 and the case-law cited).

140    Furthermore, it must be observed that, having regard, in particular, to the specific nature of each examination procedure relating to the approval of active substances, which makes comparisons particularly difficult, and to the Commission’s margin of discretion as to the manner in which it carries out investigations of such technicality and complexity, it is for the party that relies on it to establish that there were differences in the treatment of the approval procedures subject to comparison and that those differences were not objectively justified (see, to that effect, judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 311, and of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 223).

141    In the present case, the applicants allege discriminatory treatment between carbendazim and other active substances which are in an identical situation, such as propiconazole.

142    The applicants have not put the Court in a position to find that the active substances referred to were, in the present case, in a situation sufficiently similar to that of carbendazim.

143    The applicants merely submit that the proposed approval period for carbendazim is discriminatory in relation to the treatment applied to other comparable active substances, without providing any evidence to that effect. In particular, the applicants do not provide any evidence to show that those substances are sufficiently similar to carbendazim for their characteristics to be considered comparable.

144    The third plea in law must therefore be rejected.

5.      The fourth plea in law, alleging an error of law, a manifest error of assessment and misuse of powers as regards the fixing of the approval period for carbendazim

145    In support of their fourth plea in law, the applicants rely, in essence, on three parts, alleging, respectively, that the Commission erred in law, that it committed a manifest error of assessment and that it misused its powers in adopting the contested regulation. It is appropriate to examine together, first, the first two parts relating to the compliance of the approval period for carbendazim provided for in the contested regulation with the constraints linked to the rules on biocidal products and, secondly, the third part alleging misuse of powers.

146    The Commission, supported by ECHA and the French Republic, contests the arguments put forward by the applicants.

(a)    The first and second parts, alleging an error of law and a manifest error of assessment

147    The applicants consider that the Commission erred in law by setting a period for the approval of carbendazim which is incompatible with the procedural deadlines for the authorisation of biocidal products and the renewal of the approval of active substances laid down in Regulation No 528/2012. Such an error of law would render the two-stage structure established by that regulation ineffective.

148    The applicants submit that the approval of carbendazim for a period of three years also constitutes a manifest error of assessment in so far as it makes it highly unlikely, or even pointless, that authorisations would be obtained for biocidal products containing that active substance, prior to the submission of an application for renewal of the approval of that substance, in the event of refusal to renew its approval.

149    In addition, the applicants consider that the minimum approval period for carbendazim should be longer than three years because of the constraints linked, first, to the requirements of the system for consulting the potential assessing body prior to the submission of an application for renewal and, secondly, to the duration of the renewal procedure provided for in Articles 12 to 14 of Regulation No 528/2012. In their reply, the applicants add that an approval period of more than three years is not such as to call into question the objective of protecting human and animal health and the environment, taking into account the review procedure provided for in Article 15 of Regulation No 528/2012.

150    In that regard, it is sufficient to note that the regulations on biocidal products do not lay down any minimum period for the approval of active substances.

151    Both Article 10(1) of Directive 98/8 and Article 4(1) of Regulation No 528/2012 merely set a maximum initial approval period for such substances, which may not exceed 10 years.

152    Furthermore, it should be noted that the only reference to a ‘minimum period’ in those rules is the reference to Article 10(4) of Directive 98/8, according to which the renewal of the approval of an active substance may, where appropriate, be granted only for the minimum period necessary to carry out a review, following submission of an application for renewal, and will be granted for the period necessary to provide the additional information required under Article 11(2) of that directive.

153    In those circumstances, it is for the Commission to determine the approval period that it considers most appropriate, in the light of all the relevant factual circumstances and taking account of the margin of discretion that it enjoys in this matter, as set out in paragraph 51 above.

154    Admittedly, it should be noted that the approval of an active substance is, more generally, part of the authorisation procedure for a biocidal product and the renewal of the approval of that substance.

155    With regard, first, to the authorisation procedure for biocidal products, it follows from both Article 10(1) of Directive 98/8 and Article 4(1) of Regulation No 528/2012 that only active substances which are contained in at least one biocidal product that may be authorised may be approved. That rule makes it possible to avoid examining an active substance as part of the approval procedure when it cannot be used in any biocidal product that may be subject to authorisation.

156    Similarly, under Article 19(1)(a) of Regulation No 528/2012, only biocidal products whose active substances have been approved for the product type concerned may be authorised, and only if the conditions specified for those active substances are met.

157    It follows from that two-stage structure that a biocidal product cannot be authorised if the approval of only one of its active substances expires before it is authorised.

158    Secondly, as regards the procedure for renewing the approval of an active substance, Article 13(1) of Regulation No 528/2012 provides that that renewal must be applied for at least 550 days before the expiry of the approval of that substance or, in the event that different expiry dates exist for different types of products, at least 550 days before the earliest expiry date.

159    Consequently, Article 14(5) of Regulation No 528/2012 authorises the Commission to adopt a decision extending the initial approval of the expiring active substance by the period necessary to enable it to examine the renewal application in order to ensure the temporary maintenance of authorisations of biocidal products containing that active substance.

160    However, even assuming that, as the applicants maintain, compliance with a minimum approval period is necessary in practice in order not to deprive the system provided for by the rules on biocidal products referred to in paragraphs 154 to 159 above of its useful effect, it is sufficient to note that the Commission has endeavoured to preserve such a useful effect in the present case.

161    In the first place, as regards the taking into account of the authorisation procedure for biocidal products, it should be noted that, in the present case, the adoption of the contested regulation approving carbendazim took place on 25 February 2021 and the date of approval of that substance was fixed at 1 February 2022, for a period of three years.

162    As a result, applicants for authorisation of biocidal products containing carbendazim exclusively or for which it was the last approved existing substance had almost a year to submit their dossiers. Furthermore, according to Articles 29, 30 and 34 of Regulation No 528/2012, the assessment of the authorisation application would have taken approximately 29 months. It follows that the national authorisations would have been granted before the expiry date of the initial approval period for carbendazim referred to in paragraph 161 above.

163    Furthermore, it should be noted that the BPC opinions on the approval of carbendazim were adopted on 10 December 2019. Consequently, as of that date, applicants for authorisation of biocidal products already had sufficient information on the various uses that could be approved on the basis of the scientific recommendations in those opinions to begin preparing their dossiers.

164    In addition, applicants for authorisation of biocidal products already had available for their dossiers the relevant studies carried out as part of the review phase of the active substance. Furthermore, thanks to the register of biocidal products set up in accordance with Article 72 of Regulation No 528/2012 and the data-sharing procedure established by Article 62 of that regulation, potential applicants for authorisation of biocidal products were in a position to request the communication of those studies in order to use them in accordance with the rules laid down in Articles 63 and 64 of that regulation.

165    It follows from all of the foregoing that, by approving carbendazim for a period of three years, the Commission has not undermined the effectiveness of the rules on biocidal products.

166    In the second place, as regards the impact of the contested regulation on the procedure for renewal of the approval of carbendazim, it must be noted that the distinction between the date of adoption of the decision approving carbendazim, in the present case 25 February 2021, and the date of approval of the active substance, namely 1 February 2022 in the contested regulation, contributed to extending the period available to applicants for the purposes of their application for renewal of the approval of that active substance. In the present case, the period between the date of adoption of the contested regulation and the deadline for submitting such an application for renewal of the approval of carbendazim was still more than two years.

167    Thus, that duration does not prevent the submission of an application for renewal of the approval of that substance.

168    Moreover, given that the applicants are involved both in the manufacture of biocidal products containing carbendazim and in the manufacture of that substance, it should be noted that, under Article 14(5) of Regulation No 528/2012, the effects of any authorisations of biocidal products containing that substance would have been maintained until the outcome of the application for renewal of the approval of the latter.

169    It therefore follows from all the foregoing considerations that the Commission did not render the system provided for by the rules on biocidal products ineffective by adopting the contested regulation, which fixes the approval period for carbendazim at three years.

170    Consequently, the first and second parts of the fourth plea in law must be rejected.

(b)    The third part, alleging misuse of powers

171    The applicants claim, in essence, that the Commission misused its powers by adopting the contested regulation in order to anticipate the application of the exclusion criteria introduced by Article 5(2) of Regulation No 528/2012. In so doing, it pursued only the objective of protecting human and animal health and the environment, whereas Regulation No 528/2012 is also intended to improve the functioning of the internal market.

172    Having regard to the principles referred to in paragraph 111 above, there is no basis for concluding that the Commission misused its powers in the present case.

173    As pointed out in paragraph 50 above, the regulation on biocidal products pursues a twofold objective, namely to improve the free movement of biocidal products within the European Union and to guarantee a high level of protection of human and animal health and of the environment on the basis of the precautionary principle.

174    In that regard, because of the need to balance the two objectives referred to in paragraph 173 above, a broad discretion must, in principle, be conferred on the Commission (see judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 92 and the case-law cited).

175    In view of the fact that carbendazim benefited from a derogating regime, under which the assessment of the exclusion criteria laid down in Article 5 of Regulation No 528/2012 did not entail any consequences, the balancing of the two purposes referred to in paragraph 173 above must have led it to seek a compromise which fell within its margin of discretion.

176    In that regard, the consideration, in recital 9 of the contested regulation, of the need to examine as soon as possible, at EU level, in the context of a possible renewal of the approval of carbendazim, whether that substance fulfilled the conditions of Article 5(2) of Regulation No 528/2012 is fully consistent with the objective of protecting human and animal health and the environment, which prevailed in the balancing carried out by the Commission. The analysis of the exclusion criteria is carried out both during the phase of approval and renewal of the approval of the active substance and at the time of authorisation of biocidal products.

177    Thus, in view of the margin of discretion available to the Commission in the matter, it was entitled to give precedence to the objective of protecting human and animal health and the environment over that of free movement in the circumstances of the case.

178    The applicants have not adduced any objective, relevant and consistent evidence to suggest that the contested regulation was adopted for purposes other than those which they claim are legitimate.

179    Consequently, the applicants are wrong to allege misuse of powers.

180    The third part of the fourth plea in law must therefore be rejected as unfounded, as must the fourth plea in law as a whole.

6.      The fifth plea in law, alleging a manifest error of assessment, breach of the principle of non-discrimination and misuse of powers resulting from the imposition of specific conditions prohibiting the use of certain biocidal products containing carbendazim for the treatment of paint and plaster intended for outdoor use

181    In support of their fifth plea in law, the applicants rely, in essence, on three parts, alleging, respectively, that the Commission committed a manifest error of assessment, that it infringed the principle of non-discrimination and that it misused its powers by adopting the contested regulation which prohibits the use of biocidal products containing carbendazim in paints and plasters intended for outdoor use.

182    The Commission, supported by ECHA and the French Republic, contests all the arguments put forward by the applicants.

(a)    The first part, alleging a manifest error of assessment as to the specific conditions of use of biocidal products

183    The applicants submit, in essence, that the Commission committed a manifest error of assessment by imposing in the contested regulation specific conditions aimed at prohibiting the use of biocidal products containing carbendazim in paints and plasters intended for outdoor use.

184    First of all, according to the applicants, the Commission has infringed the division of powers between it and the Member States under Regulation No 528/2012 by confusing the stage of approval of the active substance, which only requires proof of the existence of a safe representative use of that substance, with that of authorisation of biocidal products, which requires an assessment of all the specific uses of those products and the risks associated with them.

185    Next, the applicants take the view that the Commission could not depart from the conclusions of the BPC opinions without setting out the reasons why it had departed from them on the basis of scientific evidence of a level at least equivalent to that of those opinions.

186    According to the applicants, neither the report of the evaluating competent authority nor the BPC opinions conclude that it is necessary to impose specific conditions at the stage of approval of carbendazim. Consequently, the Commission should have further supported its decision to depart from the conclusions of the independent scientific assessment set out in the BPC opinions with equivalent scientific evidence demonstrating the existence of an unacceptable risk for all external uses of biocidal products. In that regard, they added that the ‘countryside scenario’ had established the existence of at least one safe outdoor use of those products.

187    Moreover, the decision to include specific conditions of use was the result of political pressure exerted by certain Member States and the Parliament, as evidenced by the late proposal to the standing committee to include such conditions in the contested draft regulation.

188    Furthermore, the applicants are of the opinion that the Commission has not considered the adoption of appropriate risk mitigation measures consisting, first, in studying the applicability of a differentiated ban depending on the scenario in which the biocidal products are used, secondly, in proposing labelling including restrictive conditions for the use of those products such as the provision of protection during their application or the reduction of the area treated and, thirdly, in considering other solutions such as encapsulation or modification of the concentration of the active substance.

189    Finally, the applicants submit that, in any event, the existence of an unacceptable risk is not sufficient to impose specific conditions of use, at the stage of approval of an active substance, in so far as they constitute general and automatic prohibitions if no major concerns have been identified.

190    In the first place, it is necessary to respond to the applicants’ first argument set out in paragraph 184 above concerning the Commission's competence to impose, on the basis of the rules on biocidal products, specific conditions for the use of those products at the stage of approval of a given active substance.

191    As is clear from paragraphs 74 to 89 above, the examination of carbendazim was carried out, in accordance with the transitional rules, on the basis of the substantive requirements of Article 10(1) of Directive 98/8.

192    To that end, first, Article 10(2)(i)(d) and (f) of Directive 98/8 provides that the approval of an active substance is, if necessary, subject in particular to requirements relating to its method and field of use and to other specific conditions resulting from the assessment of information concerning the active substance under consideration.

193    Secondly, Article 19(1)(a) of Regulation No 528/2012 provides that authorisation of a biocidal product is to be granted only if all the conditions specified for the active substances approved for that type of product are met.

194    Thus, the applicable legal framework, referred to in paragraphs 192 and 193 above, authorises the Commission to prescribe, when approving an active substance, specific conditions of use for that substance which are imposed at the stage of authorisation of biocidal products containing it.

195    Consequently, the applicants are wrong to submit that, by imposing such specific conditions of use in the contested regulation, the Commission infringed the division of powers established by the rules on biocidal products.

196    In the second place, the Court considers it necessary, before examining the applicants’ arguments referred to in paragraphs 185 to 189 above, to return to the main features underlying the system for approving active substances and authorising biocidal products in order to meet the objective of protecting human and animal health and the environment, which occupies an essential place in the regulation on biocidal products (see paragraph 50 above).

197    In that regard, it should be recalled that, in the process leading to the adoption by an institution of appropriate measures to prevent certain potential risks to public health, safety and the environment under the precautionary principle, three stages can be distinguished: first, the identification of potentially adverse effects arising from a phenomenon; secondly, the assessment of the risks to public health, safety and the environment which are linked to that phenomenon; and, thirdly, where the potential risks identified exceed the threshold of what is acceptable for society, the management of the risk by the adoption of appropriate protective measures (judgments of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 60, and of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 111).

198    In the present case, in so far as the applicants do not challenge the first stage of the process referred to in paragraph 197 above, namely the identification of the potentially adverse effects of carbendazim, but rely solely on the existence of a manifest error of assessment resulting, first, from the second stage relating to the risk assessment and, secondly, from the third stage relating to the risk management measures adopted by the Commission in the contested regulation, it is appropriate to analyse those last two stages in turn.

(1)    Risk assessment

199    With regard to the risk assessment carried out by the evaluating competent authority, then by ECHA, and its consideration by the Commission, the following points should be emphasised.

200    First of all, it is clear from the report of the evaluating competent authority and the BPC opinions referred to in paragraphs 8 and 9 above respectively that carbendazim presents an unacceptable overall risk to the environment in the case of TP 7 and TP 10 intended for outdoor use and for which applications for authorisation have been submitted.

201    More specifically, it follows from the BPC opinions that, with regard to the outdoor use of paints or plasters containing carbendazim, there is an unacceptable risk for the environment, in particular surface water and sediments, for TP 7 in the ‘city scenario’ only and for TP 10 in the ‘city scenario’ and the ‘countryside scenario’.

202    Such a conclusion cannot be called into question by the arguments put forward by the applicants.

203    In the first place, the applicants submit that, in its assessment of all the uses relating to the two types of product at issue, the BPC concluded in its opinions that there was no unacceptable risk to human health.

204    However, it is sufficient to note that such a conclusion has no bearing on the conclusion relating to the existence of an unacceptable risk for the environment, reached by the BPC, in so far as those conclusions have different purposes.

205    In the second place, the applicants submit that, despite the existence of specific scenarios presenting an unacceptable risk to the environment, the BPC opinions also identified scenarios in which the outdoor use of carbendazim in biocidal products presented an acceptable risk to the environment.

206    Nevertheless, the existence of certain uses that are safe or present an acceptable risk for the environment does not call into question the finding resulting from the risk assessment of the existence of scenarios for which an unacceptable risk for the environment is proven.

207    In that regard, it follows from Article 5(1)(b)(iii) and (iv) of Directive 98/8 that authorisation of a biocidal product depends on there being no unacceptable direct or indirect effects on human or animal health or on the environment.

208    Consequently, the applicable regulations do not require that all the scenarios considered present an unacceptable risk, but only that one of them meets that condition, which is the case here.

209    Consequently, as is clear from recital 13 of the contested regulation, the Commission did not depart from the conclusions set out in the BPC opinions, which constituted its scientific basis. Accordingly, it was not required to give specific reasons for its assessment either on the basis of an additional opinion from the same committee of experts or on the basis of other evidence of at least equivalent probative value. The argument raised by the applicants, referred to in paragraph 186 above, must therefore be dismissed as unfounded.

(2)    Risk management

210    With regard to risk management and the appropriateness of the measure adopted to the risk assessment, a distinction should be made, as the Commission rightly points out, between the scientific risk assessment and the operational recommendations made by the BPC, the latter relating to the content of the risk management measure.

211    In that regard, it follows from recital 17 of Regulation No 528/2012 that ECHA is to ensure effective coordination and management of the technical, scientific and administrative aspects of that regulation. To that end, in accordance with the fifth subparagraph of Article 90(2) of that regulation, the Commission shall be assisted by ECHA in the preparation of the decisions which it is required to adopt pursuant, in particular, to Article 89(1) of that regulation.

212    First, it follows from a combined reading of Articles 8 and 9 of Regulation No 528/2012 and Article 9 of Delegated Regulation No 1062/2014 that, if the Commission adopts its decision approving or refusing to approve the active substance after obtaining ECHA’s opinion, it is not obliged to follow that opinion as regards its content. On the contrary, the Commission has a margin of discretion at the stage of adopting the risk management measure.

213    Therefore, in the present case, although the BPC, in its opinions, assesses the risks presented by carbendazim in the light of the state of scientific knowledge available at the time of that assessment, those opinions merely envisage risk management methods which cannot be interpreted as anything other than as constituting a recommendation.

214    The applicants’ argument, referred to in paragraph 185 above, must therefore be rejected as unfounded.

215    Secondly, in accordance with Article 9 of Regulation No 528/2012, upon receipt of ECHA’s opinion, the Commission shall adopt an implementing act in accordance with the review procedure referred to in Article 82(3) of that regulation.

216    As is clear from Article 82(1) of Regulation No 528/2012, the Commission is assisted by the standing committee, which is a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13).

217    In accordance with Article 3(2) of Regulation No 182/2011, that standing committee is to be composed of representatives of the Member States and chaired by a representative of the Commission.

218    The task assigned to the standing committee by Regulation No 528/2012 cannot be confused with that assigned to ECHA. Indeed, the standing committee was set up for a different purpose from that of ECHA and fulfils a distinct function.

219    In that regard, it is apparent from recitals 4, 6 and 8 of Regulation No 182/2011 that such a committee forms part of a mechanism for control by the Member States of the Commission’s exercise of its implementing powers.

220    Thus, the standing committee, once the identification of the hazard and the characterisation of the risk have been carried out by an independent, objective and transparent assessment based on the available scientific evidence, participates, in accordance with the second subparagraph of Article 9(1) of Regulation No 528/2012, in the adoption of the risk management measure by the Commission, which presupposes the prior determination of the acceptable level of risk at the risk assessment stage, according to the specific circumstances of each individual case, taking into account the available risk mitigation measures.

221    In addition, the standing committee’s participation is organised on the basis of a consultation process which involves an exchange of views on the best way to respond to the unacceptable risk to the environment identified in the BPC opinions.

222    It follows from Article 3(4) of Regulation No 182/2011 that, as long as the standing committee has not delivered an opinion, any member of the committee may propose amendments to the draft implementing act and the chair may submit amended versions thereof.

223    Accordingly, the Commission, in its capacity as chair of the standing committee, was entitled to introduce specific conditions of use into the contested draft regulation until the standing committee had delivered its opinion.

224    Moreover, as is apparent from the minutes of the 69th meeting of the standing committee of 23 September 2020, at that meeting the Commission reiterated its wish to introduce certain restrictions and stated that it would circulate a new version of the draft regulation to that end. It follows that the subsequent adoption, on 26 November 2020, of the Parliament’s resolution did not affect the introduction of the specific conditions in the contested regulation.

225    The applicants’ argument, referred to in paragraph 187 above, must therefore be rejected as unfounded.

226    Thirdly, as is clear from recital 13 of the contested regulation, the two BPC opinions concluded that there was an unacceptable overall risk to the environment and that there were no appropriate risk mitigation measures to prevent discharges into the sewage system during the useful life of paints (namely 5 years) and plasters (namely 25 years) used outdoors.

227    In that regard, it should be noted that, in the context of an application for approval submitted on the basis of the regulation on biocidal products, it is for the applicant to demonstrate that the conditions for approval are satisfied in order to obtain approval of an active substance, and not for the Commission to prove that the conditions for approval are not satisfied in order to be able to refuse it (see, by analogy, judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraphs 86 and 88).

228    Thus, pursuant to Article 8 of Directive 98/8, it is incumbent on the applicant to provide the evaluating competent authority with a complete dossier enabling it to verify whether the substance in question complies with the conditions for the approval of active substances, as defined in Article 10(1) of that directive, in the light of the precautionary principle.

229    In those circumstances, where the applicant challenges the rejection of his or her application, it is for him or her to demonstrate, before the EU Courts, that the substance in question is harmless.

230    Moreover, such a finding is corroborated by Article 7(1) of Regulation No 528/2012, which states that an application for a subsequent amendment to the conditions of approval of an active substance may always be considered provided that it is accompanied by supporting documents.

231    As pointed out in paragraphs 199 to 209 above, the applicants have not provided any evidence capable of rendering implausible the Commission’s conclusion as to the existence of an unacceptable overall risk to the environment in all outdoor uses of carbendazim for TP 7 and TP 10.

232    Nevertheless, the applicants consider that, assuming that such a risk exists, the approval of the active substance could have been subject to appropriate risk mitigation measures. To that end, they propose, in the first place, a ban differentiated according to the scenario in which the biocidal product is used, in the second place, labelling including restrictive conditions of use for those products such as the provision of protection during their application or the reduction of the area treated in order to combat the phenomenon of leaching and, in the third place, encapsulation or modification of the concentration of the active substance.

233    In that regard, the Commission rightly points out that a restriction on the placing on the market of an active substance is often the most effective measure for achieving the objective pursued by the rules on biocidal products, which is to ensure a high level of protection of human and animal health and of the environment. If a substance is not placed on the market, it cannot be used. By contrast, hypothetical restrictions prohibiting the use of such products by end users, whether professional or not, without restricting their placing on the market, would not always make it possible to manage the risk effectively (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 559).

234    Consequently, it was without committing a manifest error of assessment that the Commission concluded, in the exercise of its discretion, that a differentiated prohibition on use, limited to urban areas, of paints and plasters treated with carbendazim would not constitute an appropriate measure. The same conclusion applies to the labelling of treated articles. The applicants have not adduced any evidence to render such a conclusion implausible within the meaning of the case-law cited in paragraph 53 above.

235    Moreover, a measure targeting the application phase of biocidal products is not likely to call into question the finding that there are unacceptable environmental risks during the life cycle of those products, whether in the case of paints or plasters.

236    Accordingly, it must be held that the applicants have failed to show that the prohibition of biocidal products used in paints and plasters intended for outdoor use was not an appropriate measure in the light of the assessment of the risks posed by carbendazim.

237    Similarly, the reference made by the applicants to an ongoing study on the encapsulation technology used in biocidal products in the context of research into leaching is not, in the absence of results, such as to call into question the conclusion referred to in paragraph 234 above or the legality of the contested regulation, which is assessed in the light of the information available on the date of its adoption. The same is true of the argument based on the applicability of a differentiated prohibition, the argument based on labelling and the argument based on the change in the concentration of the active substance.

238    It should be noted that, according to settled case-law, in an action for annulment brought under Article 263 TFEU, the legality of the contested measure must be assessed in the light of the matters of fact and law existing at the date when the measure was adopted (judgments of 7 February 1979, France v Commission, 15/76 and 16/76, EU:C:1979:29, paragraph 7; of 17 May 2001, IECC v Commission, C‑449/98 P, EU:C:2001:275, paragraph 87; and of 10 September 2019, HTTS v Council, C‑123/18 P, EU:C:2019:694, paragraph 37).

239    The applicants’ argument, referred to in paragraph 188 above, must therefore be rejected as unfounded.

240    Fourthly, the existence of an unacceptable risk is sufficient to impose specific conditions of use at the active substance approval stage, even if there are no major concerns.

241    In that regard, it should be noted that the concept of ‘major concern’ does not appear either in Directive 98/8 or in Regulation No 528/2012. It is addressed only in certain documents of the Commission’s expert group, composed, inter alia, of the Member States’ national competent authorities for biocidal products, referred to in paragraph 121 above. Such documents are, however, devoid of binding legal value under Regulation No 528/2012 or on the basis of Article 288 TFEU, since only the Court of Justice has jurisdiction to provide a binding interpretation of EU law (see, to that effect, judgment of 6 September 2012, Chemische Fabrik Kreussler, C‑308/11, EU:C:2012:548, paragraphs 23 and 24). Those documents cannot therefore restrict the Commission’s power to impose specific conditions when approving an active substance.

242    In any event, it is clear from the BPC opinions that carbendazim is indeed a major concern within the meaning of the principles note.

243    The applicants’ argument, referred to in paragraph 189 above, must therefore be rejected as unfounded.

244    It follows from all of the foregoing that the Commission did not commit a manifest error of assessment by imposing, in the contested regulation, specific conditions of use for biocidal products containing carbendazim in paints and plasters intended for outdoor use.

(b)    The second part, alleging breach of the principle of non-discrimination

245    The applicants claim that carbendazim was treated differently from other active substances, in particular propiconazole, for which at least one risk classified as unacceptable had been identified in certain natural environments and which had been approved without specific restrictions relating to the authorisation of biocidal products or the placing on the market of treated articles.

246    The Commission, supported by ECHA and the French Republic, contests all the arguments put forward by the applicants.

247    The documents in the file show that the situation of several active substances that had already been approved was discussed at the 69th meeting of the standing committee on 23 September 2020. Those were, for TP 7, tebuconazole, propiconazole, folpet, tolylfluanid, fludioxonil and azoxystrobin and, for TP 10, tebuconazole, pythium oligandrum, fludioxonil and azoxystrobin.

248    In addition to those active substances, the Commission refers in its written submissions to MBM for product types 6 and 13, to creosote and cyproconazole for product type 8, to hexaflumuron for product type 18 and to dichlofuanide for product type 21. The applicants refer to CMIT/MIT and product types 6, 11, 12 and 13.

249    In that regard, it is sufficient to note that, in accordance with the case-law cited in paragraphs 139 and 140 above, the applicants have not put the Court in a position to find that the active substances referred to were, in the present case, in a situation sufficiently similar to that of carbendazim.

250    The applicants merely submit that other active substances comparable to carbendazim have been approved without restrictions on use and that the conditions imposed in the contested regulation are therefore discriminatory in relation to the treatment applied to those other substances, without providing any evidence to that effect. In particular, the applicants do not provide any evidence to show that those substances are sufficiently similar to carbendazim for their characteristics to be considered comparable.

251    Moreover, even supposing that some of those active substances are in comparable situations, the applicants have neither established the existence of differences in treatment nor put forward detailed arguments capable of demonstrating that those differences were not objectively justified (see paragraph 140 above).

252    The second part of the fifth plea in law must therefore be rejected.

(c)    The third part, alleging misuse of powers

253    The applicants submit, in essence, that the Commission misused its powers by imposing specific conditions for the use of carbendazim at the stage of approval of that active substance. In so doing, the Commission sought, in reality, to prevent the Member States from assessing, at the stage of authorisation of biocidal products, the uses which could have been authorised.

254    The Commission, supported by ECHA and the French Republic, contests the admissibility and the merits of the arguments put forward by the applicants.

255    It suffices to note, on the basis of the case-law cited in paragraph 111 above, that the applicants have not provided any objective, relevant and consistent evidence from which it could be inferred that the contested regulation was adopted exclusively or at least decisively for purposes other than those for which the power in question was conferred on the Commission.

256    Accordingly, the applicants are wrong to allege misuse of powers in the present case. It follows that no illegality of the contested regulation on that ground has been demonstrated, without it being necessary to rule on the plea of inadmissibility raised by the Commission.

257    Accordingly, the third part of the fifth plea in law must be rejected as unfounded and, consequently, the fifth plea in law must be rejected in its entirety.

7.      The sixth plea in law, alleging an error of law, a manifest error of assessment and misuse of powers resulting from the imposition of specific conditions applicable to the placing on the market of certain articles treated with carbendazim, or in which that substance is incorporated, and intended for use outdoors

258    The sixth plea in law consists of three parts, in which the applicants allege that the Commission committed, first, an error of law, secondly, a manifest error of assessment and, thirdly, a misuse of powers by concluding that the placing on the market of articles treated with carbendazim, or in which that substance is incorporated, and intended for outdoor use should be prohibited.

259    The Commission, supported by ECHA and the French Republic, contests all the arguments put forward by the applicants.

(a)    The first part, alleging an error of law in the interpretation of the provisions of Regulation No 528/2012 concerning the placing on the market of treated articles

260    The applicants consider that the Commission exceeded the legal framework delimiting its power in relation to the treated articles, enshrined in Article 58 of Regulation No 528/2012. They add, at the stage of the reply, that the Commission also erred in law in its interpretation of the transitional rules, since Directive 98/8 does not provide for assessment criteria linked to the conditions concerning the treated articles.

261    In addition, the applicants submit that there is no legal basis authorising the Commission, when approving active substances, to regulate their use in treated articles. In that regard, neither recital 52 of Regulation No 528/2012, which relates only to the question of non-discrimination between treated articles according to their origin, nor Article 15(1) or Article 58(3) of Regulation No 528/2012 could constitute such a legal basis.

262    In any event, the applicants submit that, while the Commission is competent to apply conditions relating to the treated articles, in the present case the two conditions required to do so were not met. The use of an active substance in the treated articles can only be regulated by specific conditions at the approval stage if it is appropriate and relevant, that is to say, if, first, a major concern has been identified and, secondly, the existence of that concern has been justified and its effects on the approval have been explained. The Commission would have admitted that it had not decided whether these two conditions had been met in the case in question.

263    Furthermore, in the absence of an identified major concern, the applicants submit that such specific conditions should only be introduced at the stage of authorisation of the biocidal product, which would be the appropriate time and in accordance with the existing legal framework to do so.

(1)    The Commission’s plea of inadmissibility concerning the error of law in the interpretation of the transitional rules

264    The Commission raising a plea of inadmissibility against the arguments put forward by the applicants, referred to in paragraph 260 above, as regards the error of law in the interpretation of the transitional rules. In its view, that is a new plea which was not raised in the application, which referred only to an error of law relating to Article 58 of Regulation No 528/2012.

265    Under Article 84(1) of the Rules of Procedure, new pleas in law may not be raised in the course of proceedings unless they are based on matters of law or fact which have come to light in the course of the proceedings.

266    According to the case-law, Article 84(1) of the Rules of Procedure also applies to complaints or arguments. Moreover, the generality of the heading of a plea raised at the stage of the application initiating proceedings cannot cover the development, at a later stage of the proceedings, of specific arguments which do not have a sufficiently close link with the arguments raised in that application (see judgment of 14 July 2021, AQ v eu-LISA, T‑164/19, not published, EU:T:2021:456, paragraph 59 and the case-law cited).

267    However, a plea in law or complaint which constitutes an amplification of a plea or complaint previously set out, explicitly or implicitly, in the application and which has a close link with it must be declared admissible (see judgment of 24 September 2019, Yanukovych v Council, T‑301/18, not published, EU:T:2019:676, paragraph 74 and the case-law cited). In order to be regarded as an amplification of a plea or complaint previously set out, a new argument must present, with the pleas or complaints initially set out in the application, a sufficiently close link to be capable of being regarded as resulting from the normal development of the debate in contentious proceedings (see judgment of 20 November 2017, Petrov and Others v Parliament, T‑452/15, EU:T:2017:822, paragraph 46 and the case-law cited).

268    In the present case, it must be noted that it is not at all apparent from the application that an error of law based on infringement of the transitional rules has been referred to. Indeed, in the application, the plea relating to the error of law refers solely to Article 58 of Regulation No 528/2012, to the exclusion of the impact of the transitional rules on the Commission’s competence to regulate the placing on the market of the articles treated. Moreover, none of the arguments relating to the manifest error of assessment developed in the context of that plea or in that of the fifth plea, to which the applicants refer in their entirety, presents a sufficiently close link to form the basis for such an amplification. Nor does the normal evolution of the debate in the context of the contentious procedure explain the addition of those developments, since the Commission did not refer to that provision in its defence.

269    In any event, assuming that such an argument relates to the scope of Article 58 of Regulation No 528/2012 by virtue of the transitional rules, it is sufficient to note that, first, as is apparent from a combined reading of Article 58 and Article 94 of Regulation No 528/2012, the transitional measures applicable to the articles treated relate only to the final date for placing them on the market. Secondly, in view of the factors referred to, in particular, in paragraphs 61 to 76, 154 to 157 and 191 to 194 above, the transitional rules from which carbendazim benefited only excluded the application of the substantive conditions for the approval of active substances laid down in Regulation No 528/2012, without however precluding the application of all the provisions of that regulation governing the authorisation of biocidal products and, a fortiori, those governing the placing on the market of articles treated with those biocidal products.

270    Consequently, the arguments put forward by the applicants as regards the error of law based on the failure to comply with the transitional rules must be declared inadmissible and, in any event, unfounded, assuming that they relate to the scope of Article 58 of Regulation No 528/2012.

(2)    The merits of the first part, alleging an error of law in the interpretation of Article 58 of Regulation No 528/2012

271    As is apparent from paragraphs 260 to 263 above, the applicants claim, in essence, that the Commission exceeded the legal framework which delimited its power in relation to the treated articles, enshrined in Article 58 of Regulation No 528/2012, and, in any event, that the conditions required to implement that provision were not met.

272    In the first place, as regards the Commission’s power to impose specific conditions on treated articles, it follows from a combined reading of Article 10 of Directive 98/8 together with Article 15 and Article 58(2) and (8) of Regulation No 528/2012 that the risks which an active substance may pose to human and animal health and to the environment arise only through its use in a biocidal product or its incorporation into a treated article.

273    As the Court of Justice has already held, it is the very presence of an active substance as such in a product which is likely to present a risk to the environment (judgment of 14 October 2021, Biofa, C‑29/20, EU:C:2021:843, paragraph 35).

274    The importance of the direct link with the active substance is also apparent from recitals 2 and 52 of Regulation No 528/2012, according to which it is important that all treated articles placed on the internal market contain only approved active substances, regardless of their origin, namely, whether or not they are imported from third countries.

275    In that context, Article 58 of Regulation No 528/2012 aims to regulate the placing on the market of treated articles. According to Article 58(2) thereof, that placing on the market is subject to two conditions. First, all the substances contained in the biocidal products with which the article has been treated, or which have been incorporated into it, must be approved. Secondly, all the conditions or restrictions specified in the act of approval must be met. Similarly, Article 58(3) of Regulation No 528/2012 specifies that the labelling is to include, if the conditions associated with the approval of the active substances so require, in particular because of a risk of release into the environment of the active substances concerned, any relevant instructions for use. Those provisions expressly refer to the existence of any specific conditions affecting the placing on the market of treated articles that may have been adopted at the active substance approval stage.

276    Thus, once the scientific assessment had identified risks, the Commission could consider, in the exercise of its discretion, that the imposition of specific conditions at the stage of approval of the active substance was the most appropriate solution for effectively managing those risks (see paragraphs 51 and 233 to 237 above).

277    Accordingly, it was without committing a manifest error of assessment that the Commission was able to consider that it could, on the basis of Article 58 of Regulation No 528/2012, impose specific conditions on the placing on the market of treated articles at the stage of approval of the active substance.

278    In the second place, with regard to the applicants’ argument referred to in paragraph 262 above, it is clear from the rules on biocidal products that the conditions imposed on treated articles are linked to the risks presented by the active substances with which they have been treated or which have been incorporated into them (see paragraph 272 above).

279    According to the note from the Commission’s expert group on the specific conditions to be set for the approval of active substances related to treated articles, such a major concern corresponds to cases where the active substance meets the exclusion criteria set out in Article 5(1) of Regulation No 528/2012 or where there are reasons related to the nature of the critical effect which, in conjunction with certain foreseeable use patterns, could present a risk to human health or the environment (see paragraphs 121 and 122 above).

280    In addition, it should be noted that the concept of ‘major concern’ is absent from Regulation No 528/2012. It appears only in a note by the Commission’s expert group, which has no binding legal force (see paragraphs 241 and 279 above).

281    Consequently, compliance with the criteria relating to the concept of ‘major concern’ cannot constitute a legal precondition restricting the Commission’s power to impose specific conditions relating to the treated articles when approving an active substance.

282    Consequently, the first part of the sixth plea in law must be rejected as unfounded.

(b)    The second part, alleging a manifest error of assessment as to the appropriateness of the specific conditions relating to the treated articles 

283    The applicants submit that the Commission infringed the principle of scientific excellence and the requirements laid down by the regulation on biocidal products by imposing specific conditions relating to the treated articles, when the independent scientific assessments did not lead to such a need, for the same reasons as those set out in paragraphs 183 to 189 above.

284    The Commission, supported by ECHA and the French Republic, contests all of the applicants’ arguments.

285    In the present case, it follows from the analysis of the first part of the fifth plea in law, in particular from the scientific risk assessment referred to in paragraphs 200 and 201 above, that carbendazim presents an unacceptable overall risk to the environment in relation to the active substance-types of products combination covered by TP 7 and TP 10, those products being intended for outdoor use.

286    In those circumstances, as is apparent from recital 13 of the contested regulation and from the factors referred to in paragraph 285 above, the Commission did not depart from the conclusions set out in the BPC opinions, which constituted the scientific basis for that regulation.

287    Therefore, contrary to the applicants’ assertions, the Commission was not required to give specific reasons for its assessment by relying on an additional opinion of the same committee of experts or on other evidence having a probative value at least equivalent to that of the opinion in question.

288    As regards the risk management measure, first, in view of the broad discretion conferred on the Commission (see paragraphs 50 and 51 above) and, secondly, having regard to the principles referred to in paragraphs 233 and 272 above, the Commission was entitled to conclude that the restrictions linked to the placing on the market of certain treated articles and to the authorisation of certain biocidal products formed a coherent set of measures, aimed at effectively managing the risks posed by carbendazim.

289    In addition, as the French Republic points out, the nature of the types of products for which approval of carbendazim was sought justified the laying down of specific conditions for the placing on the market of the treated articles in order to ensure the harmonised pursuit of the objectives of Regulation No 528/2012. Carbendazim serves as a systemic fungicide with a protective action that inhibits germ tube development, appressoria formation and mycelia growth (see paragraph 9 above).

290    The predominant risk to be contained with the active substance-type of products combination covered by TP 7 and TP 10, those products being protective products, lies in the life cycle of the articles treated with the biocidal products or in which they have been incorporated, in particular for the environment.

291    The Commission cannot therefore be criticised for having committed a manifest error of assessment by introducing specific conditions relating to treated articles which are in contact with the environment throughout their life in order to control the identified risks.

292    Consequently, the second part of the sixth plea in law must be rejected as unfounded.

(c)    The third part, alleging misuse of powers arising from the improper use of the system for approving active substances to regulate the placing on the market of treated articles

293    The applicants claim, in essence, that the Commission misused its powers by misusing the system for approving active substances to regulate the placing on the market of treated articles. In so doing, it exceeded the limits of Article 58 of Regulation No 528/2012.

294    The Commission, supported by ECHA and the French Republic, contests the admissibility and the merits of the arguments put forward by the applicants.

295    As is clear from the case-law cited in paragraph 111 above, the concept of ‘misuse of powers’ has a precise scope in EU law.

296    It must be noted that the applicants confined themselves to setting out the present part very succinctly in their written submissions. In particular, they do not state precisely what the alleged misuse of powers consists of.

297    The applicants provide no evidence from which it could be inferred that the contested regulation was adopted exclusively or at least decisively for purposes other than those for which the power in question was conferred on the Commission. In their reply, they confine themselves to referring to the misuse of the procedure for approving an active substance in order to regulate the placing on the market of treated articles. It follows from the analysis of the first part of the sixth plea in law that the Commission was entitled to impose such conditions in order to meet the objectives of the rules on biocidal products.

298    Accordingly, the applicants are wrong to allege misuse of powers in the present case. It follows that no illegality of the contested regulation on that ground has been demonstrated, without it being necessary to rule on the admissibility of the applicants’ arguments.

299    The third part of the sixth plea in law must therefore be rejected as unfounded.

300    Consequently, the sixth plea in law must be rejected.

8.      The seventh plea in law, alleging an error of law arising from the specific conditions imposed for the labelling of paints and plasters treated with carbendazim or in which that substance has been incorporated

301    The applicants claim that the Commission erred in law by requiring the labelling of paints and plasters treated with carbendazim, or in which that substance has been incorporated, to remind users of the specific conditions imposed by the contested regulation as regards the prohibition on using those products outdoors. In so far as, in their view, the labelling requirements laid down in the contested regulation are intended merely to reinforce those conditions, which are themselves unlawful, it follows that the obligation to affix a label to paint or plaster stating that the product must not be used outdoors is also unlawful.

302    The Commission, supported by ECHA and the French Republic, contests all the arguments put forward by the applicants.

303    It suffices to point out that, as the applicants acknowledge in their pleadings, the present plea is intrinsically linked to the question of the legality of the specific conditions for placing the treated articles on the market, which are the subject matter of the sixth plea, in so far as it is not based on any independent reasoning in relation to that plea.

304    Consequently, since the sixth plea in law has been rejected as unfounded, the seventh plea in law must also be rejected as unfounded.

C.      The request for adoption of a measure of inquiry

305    In addition to the draft presentation referred to in paragraph 25 above, the applicants requested the production of a number of documents relating to the correspondence between DG Health and Food Safety and the Commission’s Legal Service in the context of the preparation of the proposal for an implementing regulation on carbendazim.

306    In accordance with Article 91 of the Rules of Procedure, the purpose of the measures of inquiry is to make it possible to prove the truth of the factual allegations made by a party in support of its case.

307    Pursuant to Article 88(1) of the Rules of Procedure, measures of inquiry may be taken or modified at any stage of the proceedings either of the court’s own motion or at the request of a principal party.

308    Furthermore, pursuant to Article 91(b) of the Rules of Procedure, measures of inquiry may seek to request a party to provide information or produce any material relating to the case.

309    It should be noted that the Rules of Procedure confer on the General Court a discretionary power to decide whether or not to order such a measure (see, to that effect, judgment of 12 May 2010, Commission v Meierhofer, T‑560/08 P, EU:T:2010:192, paragraphs 61 and 62).

310    Where a request for the production of documents, made by a party, states precisely the grounds capable of justifying such a measure, it is for the Court to assess the relevance of that request in the light of the subject matter of the dispute and the need to take such a measure (see, by analogy, judgment of 13 May 2020, Talanton v Commission, T‑195/18, not published, EU:T:2020:194, paragraph 234 and the case-law cited).

311    However, there is no reason to order the measure of inquiry proposed by an applicant where the purpose of that measure is not to clarify the complaints raised by the applicant or to prove the truth of the applicant’s factual allegations, but is rather an attempt to obtain new evidence in support of the applicant’s claim, where the applicant does not raise concrete allegations capable of being verified or clarified by a request for specific information or documents (judgment of 11 July 2019, BP v FRA, T‑838/16, not published, EU:T:2019:494, paragraph 411; see also, to that effect, judgment of 8 November 2000, Bareyt and Others v Commission, T‑175/97, EU:T:2000:259, paragraphs 89 to 91).

312    In the present case, it must be noted that non-confidential versions of the documents relating to the procedure which led to the adoption of the contested regulation were communicated to the applicants by Commission Decision C(2021) 5968 final of 5 August 2021, following their confirmatory application of 19 May 2021 submitted on the basis of Regulation No 1049/2001 (see paragraphs 18 and 19 above).

313    In that regard, the exchange of emails between DG Health and Food Safety and the Commission’s Legal Service constitutes no more than a legal assessment based on existing scientific evidence. Its production is therefore not such as to enable the applicants to clarify their complaints or to prove the truth of their allegations in the context of the first and second pleas in law.

314    Accordingly, the information in the case file and the explanations given at the hearing and during the measures of organisation of procedure are sufficient to enable the Court to give its decision, since it was able to give a proper ruling on the basis of the forms of order sought, the pleas in law and the arguments developed during the proceedings and the documents lodged by the parties.

315    It follows that the applicants’ request for measures of inquiry must be rejected as regards the documents referred to in paragraph 313 above.

316    In the light of all the foregoing considerations, the action must therefore be dismissed in its entirety.

IV.    Costs

317    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

318    As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

319    Under Article 138(1) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. According to Article 1(2)(f) of the Rules of Procedure, the term ‘institutions’ means the institutions of the European Union referred to in Article 13(1) TEU and the bodies, offices or agencies established by the Treaties or by an act adopted in implementation thereof and which may be parties before the General Court. Under Article 100 of Regulation No 1907/2006, ECHA is an EU body. The French Republic and ECHA shall therefore each bear their own costs.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Troy Chemical Company BV and Troy Corp. to bear their own costs and to pay those incurred by the European Commission, including those relating to the interlocutory proceedings registered under number T‑297/21 R;

3.      Orders the French Republic and the European Chemicals Agency (ECHA) to each bear their own costs.

Delivered in open court in Luxembourg on 17 January 2024.

Table of contents

I. Background to the dispute and facts subsequent to the lodging of the action

II. Procedure and forms of order sought

III. Law

A. Admissibility

1. Admissibility of the action

2. Admissibility of the fourth head of claim

B. The substance

1. Preliminary observations

2. The first plea in law, alleging an error of law in the application of the transitional rules laid down in Regulation No 528/2012

(a) The first plea in law, alleging misapplication of conditions for approval not provided for in the transitional rules

(b) The second part, alleging that the transitional period of access to national markets was incorrectly taken into account

(1) The first complaint, alleging breach of the transitional rules

(2) The second complaint, alleging misuse of powers

3. The second plea in law, alleging breach of the principle of the protection of legitimate expectations

4. The third plea in law, alleging breach of the principle of non-discrimination

5. The fourth plea in law, alleging an error of law, a manifest error of assessment and misuse of powers as regards the fixing of the approval period for carbendazim

(a) The first and second parts, alleging an error of law and a manifest error of assessment

(b) The third part, alleging misuse of powers

6. The fifth plea in law, alleging a manifest error of assessment, breach of the principle of non-discrimination and misuse of powers resulting from the imposition of specific conditions prohibiting the use of certain biocidal products containing carbendazim for the treatment of paint and plaster intended for outdoor use

(a) The first part, alleging a manifest error of assessment as to the specific conditions of use of biocidal products

(1) Risk assessment

(2) Risk management

(b) The second part, alleging breach of the principle of non-discrimination

(c) The third part, alleging misuse of powers

7. The sixth plea in law, alleging an error of law, a manifest error of assessment and misuse of powers resulting from the imposition of specific conditions applicable to the placing on the market of certain articles treated with carbendazim, or in which that substance is incorporated, and intended for use outdoors

(a) The first part, alleging an error of law in the interpretation of the provisions of Regulation No 528/2012 concerning the placing on the market of treated articles

(1) The Commission’s plea of inadmissibility concerning the error of law in the interpretation of the transitional rules

(2) The merits of the first part, alleging an error of law in the interpretation of Article 58 of Regulation No 528/2012

(b) The second part, alleging a manifest error of assessment as to the appropriateness of the specific conditions relating to the treated articles

(c) The third part, alleging misuse of powers arising from the improper use of the system for approving active substances to regulate the placing on the market of treated articles

8. The seventh plea in law, alleging an error of law arising from the specific conditions imposed for the labelling of paints and plasters treated with carbendazim or in which that substance has been incorporated

C. The request for adoption of a measure of inquiry

IV. Costs

*      Language of the case: English.

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