JUDGMENT OF THE GENERAL COURT (Sixth Chamber)
3 December 2025 (*)
( Public health – Biocidal products – Decision not approving cyanamide as an existing active substance for use in biocidal products of product-types 3 and 18 – Regulation (EU) No 528/2012 – Transitional measures – Manifest error of assessment – Proportionality )
In Case T‑536/23,
AlzChem Trostberg GmbH, established in Trostberg (Germany), represented by D. Abrahams and Z. Romata, lawyers,
applicant,
supported by
Industrieverband Agrar eV, established in Frankfurt am Main (Germany), represented by H.-G. Kamann and P. Gey, lawyers,
intervener,
v
European Commission, represented by B. Cullen and R. Lindenthal, acting as Agents,
defendant,
supported by
Federal Republic of Germany, represented by J. Möller and R. Kanitz, acting as Agents,
by
Republic of Lithuania, represented by K. Dieninis and V. Kazlauskaitė-Švenčionienė, acting as Agents,
and by
European Chemicals Agency (ECHA), represented by T. Zbihlej, C. Buchanan and M. Heikkilä, acting as Agents,
interveners,
THE GENERAL COURT (Sixth Chamber),
composed, at the time of the deliberations, of M.J. Costeira, President, U. Öberg (Rapporteur) and P. Zilgalvis, Judges,
Registrar: A. Marghelis, Administrator,
having regard to the written part of the procedure,
further to the hearing on 19 March 2025,
gives the following
Judgment
1 By its action under Article 263 TFEU, the applicant, AlzChem Trostberg GmbH, seeks the annulment of Commission Implementing Decision (EU) 2023/1097 of 5 June 2023 not approving cyanamide as an existing active substance for use in biocidal products of product-types 3 and 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ 2023 L 146, p. 27, ‘the contested decision’).
I. Background to the dispute
2 The applicant is a company under German law that is currently placing on the market, in the European Union, biocidal products containing cyanamide.
3 Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured products and can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns (see 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)).
4 Cyanamide has been evaluated for use in biocidal products of product-type 3 (veterinary hygiene biocidal products) and product-type 18 (insecticides, acaricides and products to control other arthropods), as described in Annex V to Directive 98/8 which correspond respectively to product-types 3 and 18 as described in Annex V to Regulation No 528/2012 (recital 2 of the contested decision). As an existing active substance in biocidal products, cyanamide is intended for professional users for disinfection against the bacterium Brachyspira hyodysenteriae of the liquid manure stored underneath the slatted floor in pig stables in order to protect fattening pigs against the pig disease dysenteria and for the control of Musca domestica in liquid manure in pig stables.
5 After being notified as an existing active substance, cyanamide was included 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).
6 More recently, cyanamide 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.
7 On 27 April and 4 July 2006, the applicant submitted applications for approval of cyanamide 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 3 and product-type 18, respectively, as described in Annex V to Directive 98/8, which correspond, respectively, to product-type 3 and product-type 18 as described in Annex V to Regulation No 528/2012.
8 On 30 July 2013, the evaluating competent authority submitted the initial version of the evaluation report with its conclusions to the European Commission.
9 On 16 June 2016, 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 (‘the opinions of 16 June 2016’).
10 On 26 April 2018, pursuant to Article 75(1)(g) of Regulation No 528/2012, the Commission asked ECHA to revise its opinions of 16 June 2016 and to specify whether cyanamide also had endocrine-disrupting properties according to the scientific criteria laid down in Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation No 528/2012 (OJ 2017 L 301, p. 1) (‘the mandate of 26 April 2018’).
11 In a letter of 10 July 2018, the evaluating competent authority informed the applicant that, pursuant to Delegated Regulation 2017/2100, all pending applications for the active substance approval for which no decision had been taken would be subjected to an assessment of the potential application of the criteria for the determination of their endocrine-disrupting properties and that that would be applied to cyanamide. That letter also informed the applicant of the possibility of submitting additional information.
12 Accordingly, on 22 August 2018, the applicant informed the evaluating competent authority that it would submit a position paper assessing the potential endocrine-disrupting properties of cyanamide. The position paper, including an initial assessment of the endocrine-disrupting properties of cyanamide, was submitted on 15 October 2018.
13 On 20 March 2019, the evaluating competent authority sent the applicant a draft revised evaluation, which included modifications regarding the assessment of the endocrine-disrupting properties of cyanamide. Then, from 4 April 2019 to 10 May 2019, the ECHA secretariat organised a commenting phase, allowing all Member States and the applicant to comment on the draft report from the evaluating competent authority concerning cyanamide. On 26 April 2019, the applicant submitted its comments on that draft report.
14 On 4 June 2019, the revised draft report from the evaluating competent authority was reviewed at a meeting of ECHA’s Endocrine Disruptor Expert Group. At that meeting, it was concluded that cyanamide satisfied the criteria for the determination of endocrine disruptors with regard to human health.
15 Between 17 and 27 September 2019, the BPC’s Working Groups for ‘Environment’ and ‘Human Health’ met to review the assessment of the endocrine-disrupting properties of cyanamide. The applicant attended those meetings.
16 On 19 September 2019, the applicant received the revised draft BPC opinions. Following the applicant’s submission of comments on these drafts, these were reviewed at a meeting of the BPC on 10 December 2019, which the applicant attended. At that meeting, the BPC adopted its revised opinions for product-type 3 and product-type 18 and concluded that cyanamide could be approved for these two product-types (‘the opinions of 10 December 2019’). The BPC also found that cyanamide should be considered to have endocrine-disrupting properties, according to the criteria laid down in Delegated Regulation 2017/2100.
17 On 2 September 2020, the Commission asked ECHA to issue further opinions, pursuant to Article 75(1)(g) of Regulation No 528/2012, concerning the evaluation of quantitative or qualitative risks for human health and the environment that took into account the endocrine-disrupting properties of cyanamide (‘the mandate of 2 September 2020’).
18 In a letter of 14 December 2020, the evaluating competent authority allowed the applicant to propose a risk assessment for the endocrine-disrupting properties of cyanamide for product-types 3 and 18. On 29 January 2021, the applicant submitted this assessment to the evaluating competent authority.
19 Between 1 and 3 June 2021 and 15 and 16 September of the same year, the BPC’s Working Groups for ‘Environment’ and ‘Human Health’ met to discuss the cyanamide risk assessment. The applicant attended those meetings.
20 On 1 November 2021, the ECHA secretariat shared the revised version of the draft assessment report and BPC opinions with the applicant and invited it to submit comments on those documents, which the applicant did on 11 November 2021.
21 On 30 November 2021, at a meeting of the BPC, that committee adopted its revised opinions for product-types 3 and 18 (‘the opinions of 30 November 2021’), in which it concluded that ‘neither a positive nor a negative conclusion can be drawn on whether cyanamide fulfils the approval conditions of Article 4(1) of Regulation No 528/2012, in particular with regard to the criteria referred to in Article 19(1)(b)(iii) and (iv)’.
22 The Commission then submitted a draft version of the contested decision not approving cyanamide as an existing active substance for use in product-types 3 and 18 biocidal products to the Standing Committee established pursuant to Article 28 of Directive 98/8 (‘the Standing Committee’).
23 On 28 April 2023, the Standing Committee delivered a positive opinion on the draft contested decision.
24 On 5 June 2023, the Commission adopted the contested decision, Article 1 of which is drafted in the following terms:
‘Cyanamide (EC No: 206-992-3; CAS No: 420-04-2) is not approved as an active substance for use in biocidal products of product-types 3 and 18.’
II. Forms of order sought
25 The applicant claims that the Court should:
– annul the contested decision;
– order the Commission to pay the costs.
26 The Commission contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
27 ECHA contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
28 The Federal Republic of Germany contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
29 The Republic of Lithuania contends that the Court should dismiss the action.
30 Industrieverband Agrar contends that the Court should:
– annul the contested decision;
– order the Commission to pay the costs incurred by it.
III. Law
A. Substance
31 The applicant puts forward eight pleas in law in support of its action. The first plea alleges infringement of Article 90(2) of Regulation No 528/2012 concerning the transitional measures between the system under Directive 98/8 and that under the first-mentioned regulation. The second plea alleges infringement of Delegated Regulation 2017/2100. The third plea alleges infringement of the applicant’s rights of defence in that the Commission refused to allow the generation and submission of data. The fourth plea alleges infringement of the applicant’s legitimate expectations. The fifth plea in law alleges that the Commission made a manifest error of assessment in finding that cyanamide is a substance that can be classified as having endocrine-disrupting properties. The sixth plea alleges that the Commission made a manifest error of assessment in concluding that the BPC’s purported risk assessment supported the conclusion in the contested decision that cyanamide must not be approved. The seventh plea in law alleges infringement of the principles of equal treatment and non-discrimination. The eighth plea alleges infringement of the principle of proportionality.
32 As a preliminary point, it should be borne in mind that, according to the case-law, the General Court must interpret an applicant’s pleas in terms of their substance rather than of their classification (see, to that effect, judgments of 10 February 2009, Deutsche Post and DHL International v Commission, T‑388/03, EU:T:2009:30, paragraph 54, and of 25 November 2020, Kisscolor Living v EUIPO –Teoxane (KISS COLOR), T‑802/19, not published, EU:T:2020:568, paragraph 17 and the case-law cited).
33 In those circumstances, in the interests of the proper administration of justice, the Court finds that the first part of the applicant’s second plea in law must be interpreted as alleging infringement of Article 90(2) of Regulation No 528/2012 and not as alleging infringement of Delegated Regulation 2017/2100. At the hearing, the applicant stated that it accepted that interpretation of the first part of the second plea in law. That part must accordingly be addressed together with the applicant’s first plea in law.
34 Moreover, at the hearing, the applicant withdrew the fourth and seventh pleas in law, which was duly recorded.
1. Preliminary observations
35 It should be borne in mind that Directive 98/8 is aimed at improving the free movement of biocidal products in the European Union, whilst ensuring a high level of protection of both human and animal health and the environment. The same objective is also pursued by Regulation No 528/2012, which repealed and replaced that directive. In that context, Regulation No 528/2012 is underpinned by the precautionary principle to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in 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).
36 In order to enable it to accomplish effectively the task entrusted to it and having regard to the complex scientific assessments which it must make when, in the course of examining requests for approval of active substances under Regulation No 528/2012, it assesses the risks posed by the use of those substances, the Commission must be allowed a wide discretion (judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 112). The same holds true for risk management-related decisions that 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).
37 The exercise of that power is not exempt from judicial review, however. In such a situation, judicial review is confined to determining whether the relevant procedural rules have been complied with, whether the facts established by the Commission are correct and whether there has been a manifest error of appraisal of those facts or a misuse of powers. However, as regards the Commission’s conclusions which do not involve complex technical or scientific assessments, the Court has full jurisdiction to review them. Similarly, as regards questions of law, the Court can only carry out full judicial review (judgment of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 41).
38 In order to establish that an institution committed a manifest error in assessing complex facts so as to justify the annulment of an act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the decision (judgments of 21 February 2024, PAN Europe v Commission, T‑536/22, under appeal, EU:T:2024:98, paragraph 54, and of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 42).
39 Moreover, the limits to the review by the Courts of the European Union do not, however, affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (judgments of 21 February 2024, PAN Europe v Commission, T‑536/22, under appeal, EU:T:2024:98, paragraph 55, and of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 42).
40 In addition, the discretion of the EU authorities, which implies limited judicial review of its exercise, does not concern only the nature and scope of the measures to be taken but also, to some extent, the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the EU judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (judgment of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 43).
41 The questions of law in respect of which the Court is to carry out a comprehensive review include the interpretation to be given to legal provisions on the basis of objective factors and whether or not the conditions for the application of such a provision are satisfied (judgment of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 44).
42 It must also be noted that, where an institution has a wide discretion, the review of observance of certain procedural guarantees is of fundamental importance. Thus, those guarantees include the obligation for the competent institution to examine carefully and impartially all the relevant elements of the individual case and to give an adequate statement of the reasons for its decision (see, to that effect, judgments of 22 November 2007, Spain v Lenzing, C‑525/04 P, EU:C:2007:698, paragraph 58 and the case-law cited, and of 21 February 2024, PAN Europe v Commission, T‑536/22, under appeal, EU:T:2024:98, paragraph 56).
43 Thus, it has been held that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 172).
44 It is in the light of those considerations that the pleas in law put forward by the applicant in support of its action must be examined.
2. First plea in law and first part of the second plea in law put forward by the applicant: infringement of Article 90(2) of Regulation No 528/2012, relating to transitional measures concerning active substances evaluated under Directive 98/8
45 The first part of the first plea in law concerns a misuse of the powers conferred on the Commission by Article 75(1)(g) of Regulation No 528/2012, following the Commission’s request to the BPC to evaluate endocrine-disrupting properties and to carry out a risk assessment on that basis. The second part of the first plea in law and the first part of the second plea in law concern the application of the criteria laid down in Article 5 of Regulation No 528/2012, whereas only the criteria provided in Directive 98/8 should have been applied for the approval of cyanamide.
46 In the light of the content of those three parts, it is appropriate to begin by examining the second part of the first plea in law and the first part of the second plea in law, relating to the application of the criteria laid down in Article 5 of Regulation No 528/2012, followed by the first part of the first plea.
(a) Second part of the first plea in law and first part of the second plea in law: the application of the criteria laid down in Article 5 of Regulation No 528/2012
(1) Second part of the first plea in law
47 The applicant, supported by Industrieverband Agrar, submits that, when it decided not to approve cyanamide due to its endocrine-disrupting properties, the Commission in effect applied the exclusion criteria laid down in Article 5(1)(d) of Regulation No 528/2012, in breach of the transitional measures between the system under Directive 98/8 and that under Article 89 to 95 of that regulation.
48 In the first place, the applicant submits that Directive 98/8 explicitly addresses endocrine-disrupting properties only in the context of the evaluation of effects on the environment, and does not require a focus on such properties in the context of the evaluation of effects on humans, which is a unique feature of Article 5(1)(d) of Regulation No 528/2012.
49 The applicant adds that, if the material provisions of Directive 98/8 allowed for the non-approval of cyanamide on the basis of alleged endocrine-disrupting properties and subsequent risk assessment, there would not have been any need for the formal introduction of the exclusion criteria under Article 5(1) of Regulation No 528/2012. The applicant also argues that a number of active substances with endocrine-disrupting properties were approved under Directive 98/8. Lastly, according to the applicant, the Commission’s indirect reliance on the exclusion criteria under Article 5 of Regulation No 528/2012 in the present case is confirmed by its consideration, in an analysis of alternatives, of the derogations laid down in Article 5(2) of that regulation and by the public consultations relating to cyanamide.
50 In the second place, the applicant argues that the Commission’s claim that the contested decision was and could have been adopted on the basis of Directive 98/8 is not supported by the underlying facts of the case.
51 Initially, both the BPC, in its opinions of 16 June 2016 and 10 December 2019, and the Commission, in a draft implementing measure approving cyanamide as an existing active substance, considered the approval of cyanamide under Directive 98/8 possible and appropriate. The applicant asserts that the only factual difference that occurred between the two sets of positive opinions and the final opinions of 30 November 2021 from the BPC was the adoption of Delegated Regulation 2017/2100, setting out the criteria for the determination of endocrine-disrupting properties and its application to the present case.
52 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, disputes the applicant’s arguments.
53 As a preliminary point, it is appropriate to recall the context in which the transitional measures were adopted before determining whether, as argued by the applicant, the Commission made an error of law in their application.
54 In that regard, first of all, it should be noted that Directive 98/8 established, for the first time, a regulatory framework for the authorisation and placing on the market of biocidal products imposing as a condition a high level of protection for humans, animals and the environment. In particular, under that directive, the Member States could authorise the placing on the market of biocidal products only if they contained active substances listed in Annex I, I A or I B to that directive.
55 Moreover, under Article 16(2) of Directive 98/8, the Commission was to commence a 10-year programme of work for the systematic examination of all active substances already on the market on 14 May 2000. That work programme was aimed at identifying the existing active substances and determining which ones were to be examined under that programme with a view to potentially including them in Annexes I, I A or I B to Directive 98/8.
56 The rules relating to the authorisation and placing on the market of biocidal products were then drawn up at the time of adoption of Regulation No 528/2012, which repealed and replaced Directive 98/8 as from 1 September 2013. That regulation establishes new rules governing, inter alia, the establishment, at EU level, of a list of active substances capable of being used in biocidal products.
57 In order to facilitate the transition from Directive 98/8 to Regulation No 528/2012, transitional measures were laid down in Articles 89 to 95 of that regulation relating to, inter alia, the evaluation of applications for approval of active substances and authorisation of biocidal products submitted before that regulation became applicable.
58 Thus, the work programme referred to in paragraph 55 above was pursued by the Commission pursuant to Article 89(1) of Regulation No 528/2012.
59 At the same time, Article 90(2) of Regulation No 528/2012 provides that applications for evaluation submitted for the purposes of Directive 98/8 for which the Member States’ evaluation in accordance with Article 11(2) of Directive 98/8 has not been completed by 1 September 2013, are to be evaluated by the competent authorities in accordance with the provisions of that regulation.
60 It follows that the active substances for which the Member States’ evaluation has been completed by 1 September 2013 are to be evaluated in accordance with the provisions of Directive 98/8.
61 Thus, the transitional measures preclude the application of the substantive conditions for approval laid down in Regulation No 528/2012 to those substances.
62 In the present case, it should be borne in mind that cyanamide was integrated into the work programme in 2003 by Regulation No 2032/2003. It is therefore included in the existing active substances within the meaning of Article 89(1) of Regulation No 528/2012.
63 Moreover, it is not disputed that the evaluating competent authority forwarded its evaluation report to the Commission on 30 July 2013, that is to say, before the time limit referred to in paragraph 59 above.
64 Therefore, only the substantive conditions for approval laid down in Directive 98/8 were applicable to the Commission’s evaluation of cyanamide, whilst those laid down in Regulation No 528/2012 were not.
65 It is in the light of those factors that it must be determined whether, as argued by the applicant, the Commission made an error of law in the application of the transitional rules at the time of adoption of the contested decision.
66 In the present case, the contested decision was adopted on the basis of the third subparagraph of Article 89(1) of Regulation No 528/2012. Moreover, it is apparent from recital 15 of that decision that it is appropriate not to approve cyanamide for use in biocidal products of product-types 3 and 18, given that the applicant has failed to demonstrate that those biocidal products containing cyanamide meet the criteria laid down in Article 5(1)(b)(iii) and (iv), read in conjunction with Article 10(1) of Directive 98/8. It is accordingly apparent from that recital that the approval of cyanamide was subject to the substantive conditions of Directive 98/8.
67 Moreover, it is apparent from the evidence in the dossier that the legal framework providing for derogations that was applied to the examination of cyanamide in relation to the exclusion criteria laid down in Article 5 of Regulation No 528/2012 was indeed taken into account at the various stages of the procedure. Thus, all six opinions of the BPC of 16 June 2016, 10 December 2019 and 30 November 2021 refer to the fact that, though cyanamide meets the criterion laid down in Article 5(1)(d) of Regulation No 528/2012, the analysis of the derogations laid down in Article 5(2) of that same regulation is not relevant for the approval decision. Similarly, both the minutes of the 16th meeting of the BPC, held from 14 to 16 June 2016, and the minutes of the 55th meeting of the Standing Committee of 24 November 2017, confirm the application of the transitional measures.
68 Moreover, as correctly observed by the Commission, its statement of reasons for the contested decision included a risk assessment for cyanamide (see, for example, recital 13 of the contested decision), as provided for in Article 5(1)(b)(iii) of Directive 98/8. Had the Commission applied the exclusion criteria laid down in Article 5 of Regulation No 528/2012, as argued by the applicant, such a risk assessment would not have been necessary, as the refusal to approve cyanamide could have been based solely on the fact that it had endocrine-disrupting properties. It would then have been for the applicant to demonstrate that cyanamide satisfied at least one of the conditions laid down in Article 5(2) of that regulation. It cannot be inferred from the dossier that the Commission requested such evidence from the applicant.
69 As a result, the substantive conditions of Directive 98/8 were applied for the purposes of adopting the contested decision, in accordance with the transitional measures.
70 Such a conclusion is not capable of being called into question by the following four factors, put forward by the applicant.
71 First, the applicant submits that the provisions of Directive 98/8 do not contain any decisive rule concerning endocrine-disrupting properties in the context of the evaluation of effects on humans.
72 In that regard, it is clear that, according to the wording of Article 5(1)(b) and Article 10(1) of Directive 98/8, in order for an active substance to be approved under that directive, with a view to being used in biocidal products, it is necessary, inter alia, that the biocidal products containing that substance do not have an unacceptable effect on human or animal health, or on the environment.
73 Under Article 8(2)(a) of Directive 98/8, it was for the applicant to submit to the evaluating competent authority a complete dossier enabling the latter to ascertain whether the cyanamide complied with the approval criteria for active substances, as defined in Article 5(1) of that directive. The evaluation principles to be applied in the examination of that dossier were those listed in Annex VI to Directive 98/8. Paragraphs 20 and 21 of that annex, relating to effects on humans, refer to the fact that the risk assessment must take account of potential effects, including ‘any other special properties of the active substance or substance of concern’, which must be construed as comprising endocrine-disrupting properties.
74 As observed by the applicant, there is an explicit reference to endocrine disruption in paragraph 38 of Annex VI to Directive 98/8 relating to ‘effects on the environment’. Nevertheless, that fact and the lack of explicit reference to endocrine disruption in paragraphs 20 and 21 of that annex are not, in themselves, capable of establishing, a contrario, the wish of the EU legislature to exclude endocrine-disrupting properties from the evaluation of effects on humans to be carried out under Directive 98/8.
75 In that regard, the Court notes that paragraph 38 of Annex VI to Directive 98/8 contains a non-exhaustive list of effects and impacts of a substance of concern. The fact that the endocrinal effects are referred to in paragraph 38 as a property of an active substance of particular concern confirms that the endocrinal effects must also be considered to be covered by the category ‘any other special properties of the active substance or substance of concern’ referred to in paragraph 21 of that annex.
76 It follows that, although the legal consequences attaching to the classification of an active substance as having endocrine-disrupting properties have evolved with the adoption of Regulation No 528/2012, the fact remains that those are relevant characteristics of an active substance for evaluating the risk profile of those active substances, both for the environment and for humans under Directive 98/8.
77 Therefore, the application of the substantive conditions of Directive 98/8, instead of those of Regulation No 528/2012, did not prohibit the Commission from taking account of endocrine-disrupting properties of an active substance in order to evaluate the risk profile of that substance.
78 Contrary to the applicant’s assertions, that interpretation of Directive 98/8 does not mean that there would be no point in formally introducing the exclusion criteria laid down in Article 5(1) of Regulation No 528/2012.
79 As observed by the Commission, under Article 5(1)(d) of Regulation No 528/2012, approval for cyanamide could have been refused because of the mere endocrine-disrupting hazard and not only because of unacceptable risks, as was the case here.
80 Secondly, according to the applicant, the Commission’s indirect reliance on the exclusion criteria under Article 5 of Regulation No 528/2012 in the present case is confirmed by its consideration, in an analysis of alternatives, of the derogations laid down in Article 5(2) of that regulation and by the public consultations relating to cyanamide, which focused on alternatives.
81 The analysis of alternatives is contained in an appendix to a letter from the Commission dated 10 June 2022, responding to a letter from the applicant dated 11 March 2022. In that regard, the Court notes that the Commission’s list of those alternatives in that appendix must be regarded as being a response to the applicant’s statement, in its letter of 11 March 2022, to the effect that no such alternatives exist. Consequently, the list of alternatives in the appendix to the Commission’s letter of 10 June 2022 does not mean that, in its statement of reasons for the contested decision, the Commission actually based its evaluation of cyanamide on Article 5 of Regulation No 528/2012.
82 As regards the public consultations relating to cyanamide, the Court notes that, under Article 21 of the Statute of the Court of Justice of the European Union and Article 76 of the Rules of Procedure of the General Court, the applicant’s argument is inadmissible inasmuch as it merely refers to a link set out in a footnote in the application, without referring to any specific evidence, potentially included in that link, in support of that argument.
83 Moreover and in any event, the Court notes that, in its statement in defence, the Commission stated that the public consultation by ECHA was held in order to provide information to Member States on the availability of alternatives and assist them with carrying out the comparative assessment required at the product authorisation stage and deciding whether conditions for derogation under Article 5(2) of Regulation No 528/2012 would be met if cyanamide had been ultimately approved, a point not disputed by the applicant in its reply.
84 Thirdly, as regards the applicant’s argument to the effect that a number of active substances with endocrine-disrupting properties were approved under Directive 98/8, the Court notes, in line with what was observed by the Commission, that, unlike cyanamide, those substances were not clearly identified as substances having endocrine-disrupting properties for human health and the environment at the time of their initial approval, a point not disputed by the applicant. Consequently, any comparison of those active substances and cyanamide is neither possible nor relevant in the present case.
85 Fourthly, the applicant argues that the Commission’s claim that the contested decision could have been adopted on the basis of Directive 98/8 is not supported by the underlying facts of the case. More specifically, the applicant states that the BPC, in its opinions of 16 June 2016 and 10 December 2019, and the Commission, in a draft implementing measure approving cyanamide as an existing active substance, examined the endocrine-disrupting properties of cyanamide and concluded that they did not preclude its approval, at the time of application of the criteria laid down in Directive 98/8. Thus, according to the applicant, the evolution of the Commission’s position in the contested decision, as compared with its previous position, reflects the application of the criteria laid down in Regulation No 528/2012.
86 In that regard, the Court finds that a risk assessment of cyanamide’s endocrine-disrupting properties was carried out for the first time in the BPC’s opinions of 30 November 2021. In the light of the foregoing, the evolution of the Commission’s position in the contested decision, as compared with its previous position, is justified and does not support the applicant’s argument to the effect that the Commission applied the exclusion criteria laid down in Article 5(1)(d) of Regulation No 528/2012, contrary to the transitional rules.
87 Therefore, the second part of the applicant’s first plea in law must be rejected.
(2) First part of the second plea in law
88 The applicant submits that cyanamide is not subject to the substantive evaluation criteria under Regulation No 528/2012, by virtue of Article 90(2) thereof. Those substantive criteria in Regulation No 528/2012 include the application of Article 5. Since the legal basis for Delegated Regulation 2017/2100 is Article 5(3) of Regulation No 528/2012, it does not apply in the context of the evaluation of cyanamide.
89 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, submits that the first part of the second plea in law must be rejected as inadmissible and, in any event, unfounded.
90 As stated in paragraph 64 above, in the present case only the substantive conditions for approval laid down in Directive 98/8 were applicable to the Commission’s evaluation of cyanamide, whilst those laid down in Regulation No 528/2012 were not.
91 The legal basis for Delegated Regulation 2017/2100 is Article 5(3) of Regulation No 528/2012. Delegated Regulation 2017/2100 specifies the scientific criteria for determining endocrine-disrupting properties as referred to in Article 5(1)(d) of Regulation No 528/2012.
92 In that regard, it is true that the scientific criteria for determining endocrine-disrupting properties constitute an assessment criterion in the approval procedure for an active substance under Regulation No 528/2012.
93 However, the classification of an active substance as having endocrine-disrupting properties results, more generally, from the relevant characteristics linked to the toxicological profile of an active substance and is per se a relevant fact in the evaluation of that active substance, irrespective of the application of transitional rules.
94 Thus, as stated in paragraph 76 above, it is noteworthy that the classification of an active substance as having endocrine-disrupting properties was already taken into account in Directive 98/8.
95 Moreover, although Directive 98/8 did not expressly lay down provisions defining the criteria for determining whether an active substance can be categorised as having endocrine-disrupting properties, Article 10 thereof provides that the evaluation for determining whether an active substance may be approved must be carried out in the light of current scientific and technical knowledge.
96 In that context, it follows from recital 7 of Delegated Regulation 2017/2100 that the criteria laid down therein for the determination of endocrine-disrupting properties are to reflect the current state of scientific and technical knowledge and allow for substances having those properties to be identified more accurately, a point not disputed by the applicant.
97 It follows therefrom that the application of the substantive conditions of Directive 98/8 under the transitional rules did not prohibit the Commission from taking into account all relevant facts in the evaluation of applications for approval of active substances. That included, inter alia, the classification of the active substance as having endocrine-disrupting properties within the meaning of Delegated Regulation 2017/2100.
98 Therefore, the evaluation of cyanamide’s risk profile under Directive 98/8 presupposes that account is taken of the criteria laid down in Delegated Regulation 2017/2100 for the determination of endocrine-disrupting properties, which is a relevant characteristic in fact and in law linked to the toxicological profile of cyanamide.
99 Therefore, the fact that cyanamide was evaluated in the light of the criteria for the determination of endocrine-disrupting properties established by Delegated Regulation 2017/2100 does not amount to an infringement of the transitional rules laid down in Article 90(2) of Regulation No 528/2012.
100 It follows that the first part of the second plea in law must be rejected, without it being necessary to rule on the plea of inadmissibility put forward by the Commission.
(b) First part of the first plea in law: misuse of powers by the Commission
101 The applicant submits that the Commission misused its powers under Article 75(1)(g) of Regulation No 528/2012 and unlawfully used the mandates of 26 April 2018 and 2 September 2020 in order to apply the exclusion criteria laid down in Article 5 of that regulation. According to the applicant, by asking the BPC, in the mandate of 26 April 2018, to evaluate cyanamide in accordance with the scientific criteria for the determination of endocrine-disrupting properties contained in Delegated Regulation 2017/2100 and, in the mandate of 2 September 2020, to evaluate the level of risks to humans and the environment of cyanamide as a consequence of those criteria, the Commission misused the mandate processes in order to apply the substantive considerations of the exclusion criteria laid down in Article 5(1) of Regulation No 528/2012 to the evaluation of cyanamide, in breach of Article 90(2) of Regulation No 528/2012.
102 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, disputes the applicant’s line of argument.
103 As a preliminary point, it should be borne in mind that the concept of ‘misuse of power’ refers to cases where an administrative authority has used its powers for a purpose other than that for which they were conferred on it (judgment of 4 February 1982, Buyl and Others v Commission, 817/79, EU:C:1982:36, paragraph 28).
104 In the present case, the requests under Article 75(1)(g) of Regulation No 528/2012 are vitiated by a misuse of power only if it appears, on the basis of objective, relevant and consistent facts, to have been taken solely, or at the very least decisively, for purposes other than those for which the power in question was conferred (see, by analogy, judgments 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).
105 There is nothing in the present case supporting a finding that the Commission misused its powers.
106 The applicant has not provided any objective facts on the basis of which it could be found that the mandates of 26 April 2018 and 2 September 2020 were requested solely, or at the very least decisively, for purposes other than those for which the power in question was conferred on the Commission.
107 In that regard, the Court notes that, under Article 75(1)(g) of Regulation No 528/2012, the BPC is responsible for preparing the opinion of ECHA on ‘any other questions that arise from the operation of [Regulation No 528/2012] relating to technical guidance or risks to human health, animal health or the environment’.
108 Under the mandate of 26 April 2018, the Commission requested the BPC to prepare revised opinions and to evaluate the endocrine-disrupting properties of cyanamide in accordance with the criteria for the determination of those properties laid down in Delegated Regulation 2017/2100.
109 It is apparent from the minutes of the meeting of 24 November 2017 of the Standing Committee that that mandate was aimed at ensuring that the final decision would take account of the criteria laid down in Delegated Regulation 2017/2100 for the determination of endocrine-disrupting properties reflecting the current state of scientific and technical knowledge.
110 It should also be noted that, if the BPC had found that cyanamide did not satisfy the requirement laid down in Delegated Regulation 2017/2100 relating to endocrine-disrupting properties, cyanamide could have been approved without it being necessary to conduct a risk assessment of those properties and without any restrictions.
111 Therefore, that is a relevant question relating to risks for human health and the environment, coming within the scope of Article 75(1)(g) of Regulation No 528/2012.
112 Under the mandate of 2 September 2020, the Commission requested the BPC to evaluate the risks for human health and the environment by integrating those linked to the endocrine-disrupting properties of cyanamide.
113 In that regard, the Court finds that the BPC opinions of 16 June 2016 and 10 December 2019 did not contain a risk assessment of the endocrine-disrupting properties of cyanamide. It is apparent from the mandate of 2 September 2020 that the Commission was seeking to obtain such an assessment, which was necessary for determining whether or not cyanamide could be approved.
114 Consequently, in the mandate of 2 September 2020, the Commission requested the BPC to provide clarification on a question necessary for deciding whether cyanamide could be approved as an active substance under Directive 98/8.
115 The applicant is accordingly incorrect in arguing that there has been a misuse of powers, as it has not proven any illegality on that basis.
116 In the light of the foregoing, the first part of the first plea in law must be rejected, as must also the first plea in law in its entirety.
3. Second part of the second plea in law: infringement of Delegated Regulation 2017/2100
117 The applicant, supported by Industrieverband Agrar, submits that although Delegated Regulation 2017/2100 can legally be applied in the present case, it follows from recital 7 thereof that the Commission ought to have requested additional information, which it did not do in any meaningful way. That constitutes a breach of the requirements laid down in Delegated Regulation 2017/2100.
118 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, submits that the second part of the second plea in law must be rejected as inadmissible and, in any event, unfounded.
119 In that regard, the Court notes, in the first place, that recital 7 of Delegated Regulation 2017/2100 does not provide for an unconditional right for applicants to submit additional information. On the contrary, recital 7 merely states that the Commission may request additional information in cases where the criteria for the determination of endocrine-disrupting properties established by that regulation are applied to procedures under way pursuant to Regulation No 528/2012.
120 In the second place, as stated in paragraphs 11 and 12 above, in the present case, in a letter of 10 July 2018, the evaluating competent authority informed the applicant of the possibility of submitting additional information. In response to that letter, on 15 October 2018, the applicant submitted a position paper, including an assessment of the endocrine-disrupting properties of cyanamide, in accordance with the criteria of Delegated Regulation 2017/2100.
121 Thus, the applicant clearly had the opportunity to submit additional information following the adoption of Delegated Regulation 2017/2100 and it is common ground that it availed itself of that opportunity. It follows that, in any event, in the present case the Commission acted in accordance with the requirements of sound administration alluded to in recital 7 of that regulation.
122 Therefore, the second part of the second plea in law must be rejected, without it being necessary to rule on the plea of inadmissibility put forward by the Commission.
4. Third plea in law: infringement of the applicant’s rights of defence
123 The applicant, supported by Industrieverband Agrar, submits that the Commission infringed its rights of defence, its right to be heard and the principle of sound administration in refusing to allow it to generate and submit relevant data.
124 On 22 August 2018, the applicant suggested that several studies be conducted to make it possible to examine a potential effect of cyanamide on the thyroid in a comprehensive manner (‘the suggested studies’). Furthermore, on 5 August 2021, the applicant proposed conducting a developmental neurotoxicity study for human health risk assessment purposes (‘the neurotoxicity study’). By prohibiting the applicant from generating and submitting those studies, the Commission deprived the applicant of the possibility to effectively make its views known, in breach of the right to be heard.
125 If the applicant had been allowed to generate and submit the suggested studies and the neurotoxicity study, they could have led to a different outcome of the decision-making process in the contested decision in relation to approval of cyanamide.
126 First of all, the suggested studies would have made it possible to investigate the underlying mode of action of cyanamide. The determination of the mode of action of a substance for mechanistic studies is fundamental in order to establish whether there is human relevance for the findings made.
127 Next, the neurotoxicity study could have addressed some uncertainties surrounding thyroid-mediated adversity and thyroid-related endocrine activity. Because of those uncertainties, it is not possible to reliably establish a plausible link between cyanamide-related adversity and activity.
128 The applicant adds that, in Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation No 528/2012 (OJ 2021 L 106, p. 3), the Commission recognised the importance of the neurotoxicity study and most of the suggested studies for an assessment of endocrine disruption.
129 Moreover, according to the applicant, the facts of the present case differ from those that gave rise to the judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission (T‑337/18 and T‑347/18, EU:T:2021:594). In the first place, in the case of cyanamide, the applicant’s procedural rights, as set out in Regulation No 528/2012 and Delegated Regulation 2017/2100, have been breached. In the second place, the competent authorities conducted new hazard and risk assessments requiring new information, which ultimately led to the Commission’s contested decision, after the validation of the dossier had occurred. Yet, in the aforementioned judgment, the applicant had tried to replace existing data, which had been rejected by the authorities, with new information. In the third place, it has been recognised expressly, in the decision-making process leading up to the contested decision that the additional information, which the applicant suggested it could generate and submit on its own initiative, would have been helpful for the assessment of cyanamide.
130 Industrieverband Agrar adds that the applicant has the right to complement the dossier as a consequence of changes in circumstances. That right derives from the general principle of good administration enshrined in Article 41(1) and (2) of the Charter of Fundamental Rights of the European Union, as reflected in Article 90(2) of Regulation No 528/2012 and in recital 7 of Delegated Regulation 2017/2100.
131 Moreover, the Court recognised, in paragraph 177 of the judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission (T‑337/18 and T‑347/18, EU:T:2021:594), that, beyond the specific provisions granting an applicant the right to submit new information in the course of the validation of the dossier in specific circumstances, it was necessary to take account of new documents or new data submitted by the applicant, which were not available at the time when the dossier was validated.
132 In the present case, the approval procedure took approximately 16 years and during that period, the regulatory circumstances changed at least three times. In view of those circumstances, the evaluation authorities should have granted the applicant, subsequent to the second mandate of 2 September 2020, the right to conduct and submit additional studies to complement the dossier within a reasonable time frame of two years.
133 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, submits that the third plea in law is unfounded.
134 It should be borne in mind that, according to settled case-law, observance of the rights of the defence in all proceedings initiated against an entity which may lead to a measure adversely affecting that entity, is a fundamental principle of EU law which must be guaranteed, even when there are no rules governing the procedure in question. That principle requires that a person whose interests are significantly affected by a decision addressed to him or her must be given the opportunity to make his or her point of view known (see, to that effect, judgments of 15 June 2006, Dokter and Others, C‑28/05, EU:C:2006:408, paragraph 74, and of 9 September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph 130). The right to be heard in an administrative procedure taken against a specific person is a corollary of the rights of the defence (see judgment of 12 December 2014, Xeda International v Commission, T‑269/11, not published, EU:T:2014:1069, paragraph 108 and the case-law cited).
135 By contrast, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, in accordance with the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case if an express provision of the legal framework governing the adoption of that act confers a procedural right on a person affected (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 87 and the case-law cited).
136 In the present case, the contested decision contains a measure of general application which precludes approval of cyanamide as an existing active substance intended for use in product-type 3 and product-type 18.
137 Thus, the applicant’s procedural rights in the procedure for the approval of cyanamide were those explicitly provided for in Regulation No 528/2012 and in Delegated Regulation No 1062/2014.
138 In that regard, it should be borne in mind that the approval procedure for active substances, provided for in Chapter II of Regulation No 528/2012, is based on the submission of an application for approval. Under Article 6 of that regulation, it is for the applicant to submit to the competent authority a complete dossier enabling the latter to ascertain whether the substance at issue complies with the approval criteria for active substances as defined in Article 4(1) of that directive, read in the light of the precautionary principle.
139 As is apparent from Article 7(3) and (4) of Regulation No 528/2012, after having accepted an application for approval, the evaluating competent authority may, where it considers that the application is incomplete, grant the applicant an additional time limit, not normally exceeding 90 days, in which to submit the required information. If the dossier remains incomplete upon expiry of that time limit, the application may not be approved and is accordingly dismissed.
140 However, the fact that a dossier has been declared complete by the evaluating competent authority under the first subparagraph of Article 7(3) of Regulation No 528/2012 does not necessarily guarantee that it contains all the information enabling the evaluating competent authority, ECHA and the Commission to adopt a position on the hazards of the active substance in question. For that reason, Article 8(2) of Regulation No 528/2012 provides for the possibility for the evaluating competent authority to ask applicants to submit additional information necessary for clarification of the dossier. However, as it is for the applicant to ensure that the dossier submitted is complete, that provision does not make any provision for the applicant to be allowed to complete the file on its own initiative.
141 Nevertheless, it is apparent from the ECHA document entitled ‘Biocidal Products Committee – Introducing new information during the peer review process of active substance approval’ of 20 January 2016, applicable to the present case, that, in practice, it is sometimes necessary for ECHA as well to gather additional information in the course of that process. Part 3 of that document nevertheless states that the submission of such information is subject to observance of four criteria: first, the 270-day time limit for ECHA to issue its opinion must be adhered to; secondly, it must become apparent in the course of the process that the outcome of the evaluation of the evaluating competent authority may have significantly changed; thirdly, the new information must already be available and capable of being submitted immediately after the meeting of the relevant working group; and, fourthly, that working group must have agreed that new information was required and which information that was.
142 Consequently, in an evaluation of an active substance under Regulation No 528/2012 and Delegated Regulation No 1062/2014, neither the evaluating competent authority nor ECHA are required to accept any new study or additional information that an applicant may wish to submit to them on its own initiative after that applicant’s dossier has been found to be complete and thus validated by the evaluating competent authority.
143 In the present case, as stated in paragraphs 12, 13, 15, 16 and 18 to 20 above, the Court finds that the applicant has had the opportunity to submit its observations to the evaluating competent authority at each stage of the procedure commenced further to its application for approval of cyanamide as an active substance for product-type 3 and product-type 18.
144 In particular, it is clear, as stated in paragraphs 12 and 18 above, that the applicant was invited by the evaluating competent authority to submit its comments on the evaluation of the endocrine-disrupting properties of cyanamide, following the adoption of the mandate of 26 April 2018, and on the risks arising from the endocrine-disrupting properties of that substance, following the adoption of the mandate of 2 September 2020, and that it did indeed submit such comments.
145 Moreover, the applicant attended meetings of the BPC’s Working Groups, at which the risks posed by cyanamide were examined, and also the BPC’s meetings of 10 and 11 December 2019 and 29 November to 3 December 2021. In that context, the Court notes that the applicant does not dispute that it was given the opportunity to submit comments during the decision-making process.
146 It follows that the applicant was invited to submit its comments and that it did so in writing and at the BPC meetings which it attended. In those circumstances, the Court finds not only that the Commission did not breach any rights of the defence, but that, moreover, the applicant actually exercised those rights of the defence.
147 That conclusion is not called into question by the arguments put forward by the applicant and Industrieverband Agrar.
148 First, as regards the suggested studies and the neurotoxicity study, it should be borne in mind, as stated in paragraph 142 above, that neither Regulation No 528/2012 nor Delegated Regulation No 1062/2014 provides for the possibility for the applicant to submit new studies or information to the evaluating competent authority, or ECHA, after that applicant’s dossier has been validated by the evaluating competent authority. Consequently, the applicant’s right to be heard was not breached by the refusal of the evaluating competent authority and the Commission to accept the suggested studies and the neurotoxicity study.
149 As regards the applicant’s arguments to the effect that there are reasons for taking a different approach in the present case from that taken by the Court in the judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission (T‑337/18 and T‑347/18, EU:T:2021:594), it is true that the present case is different from the one giving rise to that judgment, in that the scientific criteria for evaluating endocrine-disrupting properties have evolved in the course of the evaluation of cyanamide.
150 Nevertheless, evolution in current scientific and technical knowledge since the notification does not give persons who have notified an active substance and who are facing the probability of a decision not to approve that substance an unlimited opportunity to submit new studies and information for as long as doubts about the innocuousness of that active substance persist.
151 In that regard, it should be borne in mind that there has been no change in the regulatory situation as alleged by the applicant. In fact, as stated in paragraph 69 above, the Commission examined cyanamide in the light of the substantive criteria for approval laid down in Directive 98/8.
152 Moreover, the mandate of 26 April 2018 requested ECHA to evaluate cyanamide in the light of the scientific criteria for the determination of endocrine-disrupting properties, as established by Delegated Regulation 2017/2100, and the mandate of 2 September 2020 requested ECHA to evaluate the risks arising from the endocrine-disrupting properties of cyanamide. The latter enabled ECHA to request additional information from the applicant. As stated in paragraphs 12 and 18 above, the applicant then took advantage of those opportunities to submit, on 15 October 2018, a position paper, including an assessment of the endocrine-disrupting properties of cyanamide, in the light of the scientific criteria for the determination of endocrine-disrupting properties, as established by Delegated Regulation 2017/2100 and, on 29 January 2021, a risk assessment for the endocrine-disrupting properties of cyanamide for product-types 3 and 18.
153 As a result, the applicant had ample opportunity to submit comments on the scientific criteria for the determination of endocrine-disrupting properties, which were drawn up when cyanamide was being evaluated and which evolved over the course of that evaluation.
154 Secondly, as regards the applicant’s argument to the effect that it was expressly recognised that the additional information it proposed generating and submitting on its own initiative would have been helpful for the assessment of cyanamide, the Court notes that the possibility of accepting the suggested studies was discussed during the meeting of ECHA’s Endocrine Disruptor Expert Group on 4 and 5 June 2019. The experts of the Member States agreed that the information available was sufficient to conclude that cyanamide is a substance having endocrine-disrupting properties with regard to human health.
155 The neurotoxicity study was rejected on the ground that it was submitted out of time, as is apparent from the minutes of the meeting of the ECHA Working Group for Human Health of 1 June 2021. It is true that some attendees at that meeting, which was also attended by the applicant, expressed the view that a developmental neurotoxicity study could be useful for determining a threshold for the observed effects on the thyroid. Nevertheless, it is apparent from the minutes of that meeting, that nor were other modalities, namely oestrogen, androgen and stereoidogenic modalities, fully addressed. Thus, as stated by the Federal Republic of Germany, even if account had been taken of a developmental neurotoxicity study, that would not have made it possible to address uncertainties surrounding the most sensitive effects and, therefore, to establish a threshold. Consequently, even if the neurotoxicity study could have been useful for demonstrating a threshold for the observed effects on the thyroid, it would not have been able to dispel existing uncertainties. Thus, conducting a developmental neurotoxicity study would have at most caused a major delay in the decision-making, without bringing about any substantive change.
156 As a result, it is apparent from the dossier that, as part of its discretion in assessing complex scientific facts, the Commission found that the suggested studies and the neurotoxicity study, although potentially useful, were not necessary in the present case.
157 In so far as the applicant’s argument is aimed at supporting its claim that the Commission thereby made a manifest error of assessment, it overlaps with those put forward under the applicant’s sixth plea in law and will, accordingly, be examined under that plea.
158 In so far as the applicant’s argument alleges infringement of its rights of defence, it is appropriate to emphasise that those rights do not comprise an unlimited right to make applications to conduct new studies at any point during the procedure. Were it so, applicants would be entitled to prolong the evaluation procedure indefinitely, thereby making it impossible to adopt any decision on the risks posed by the substance being evaluated, whilst that substance is on the EU market pending adoption of that decision.
159 Thirdly, as regards the applicant’s argument to the effect that, in Delegated Regulation 2021/525, the Commission recognised the importance of the neurotoxicity study and of most of the studies proposed for an evaluation of the endocrine disruption, in the first place, the Court finds that that delegated regulation does not apply to new applications submitted after 15 April 2022 or, on a voluntary basis, after 15 April 2021 and, therefore, does not apply in the present case. In the second place, the fact that the neurotoxicity study and most of the suggested studies considered to be relevant for the evaluation of new applications for approval of biocidal products does not mean that the Commission infringed the applicant’s rights of defence in the present case by refusing to authorise the applicant to generate and submit those studies on its own initiative. As stated in paragraph 158 above, the rights of the defence do not comprise an unlimited right for the applicant to make applications to conduct new studies. It should be noted in that regard that, in the present case, the Commission found that the suggested studies and the neurotoxicity study were not necessary.
160 Fourthly, as regards Industrieverband Agrar’s arguments, it is clear that the third subparagraph of Article 90(2) of Regulation No 528/2012 confers on applicants the right to provide additional information where the evaluation identifies concerns arising from the application of provisions of that regulation which were not included in Directive 98/8. However, that provision applies only to applications submitted on the basis of Directive 98/8 for which the report of the evaluating competent committee has not been completed as at 1 September 2013. Consequently, the third subparagraph of Article 90(2) of Regulation No 528/2012 does not cover a substance such as cyanamide, evaluated in the light of the substantive conditions laid down in Directive 98/8, for which the evaluation of the evaluating competent authority was completed before 1 September 2013. For that reason alone, no independent right to submit additional information by way of new studies for inclusion in the new file may be inferred from that provision.
161 Nor may such a right be inferred from recital 7 of Delegated Regulation 2017/2100. As stated in paragraph 119 above, that recital is not a binding legal provision, but merely reiterates that the Commission may request additional information from the applicant. Hence, that recital does not provide for a right to carry out new studies.
162 It is true that there is a right, in specific circumstances, to submit new information during the procedure for validating the dossier. Those specific circumstances correspond to a situation such as that envisaged in the ECHA document, referred to in paragraph 141 above. In that context, the Court finds that no new information was available. On the contrary, the applicant wished to proceed with new studies. It follows that the third condition is not satisfied in the present case. Consequently, in the present case, there are no specific circumstances such as referred to in paragraph 177 of the judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission (T‑337/18 and T‑347/18, EU:T:2021:594) supporting the applicant’s claims.
163 In the light of the foregoing considerations, the applicant may not claim that its right to be heard was infringed in the procedure that led to the adoption of the contested decision. That decision is not based on any factor on which the applicant was not given the opportunity to express its views during the evaluation procedure which, moreover, lasted over 17 years.
164 The third plea in law is accordingly unfounded and must be rejected.
5. Fifth plea in law: manifest error of assessment by the Commission inasmuch as it found in the contested decision that cyanamide has endocrine-disrupting properties
165 By its fifth plea in law, the applicant alleges that the Commission made a manifest error of assessment in finding, in the contested decision, that cyanamide has endocrine-disrupting properties on the basis of information that is vitiated by fundamental deficiencies. Yet, in the absence of the suggested studies and the neurotoxicity study, it is not possible to draw a reliable conclusion regarding the endocrine-disrupting properties of cyanamide.
166 According to the applicant, the evaluation of cyanamide’s endocrine-disrupting properties is based primarily on the results of in vitro thyroperoxidase (TPO) inhibition assays, which are, on the whole, contradictory to a large in vivo dataset, including human data. Moreover, the applicant submits that a weight-of-evidence approach was not applied and that key findings were not taken into account.
167 In support of its arguments, the applicant cites a report by James Bridges, emeritus Professor of Toxicology and Environmental Health, prepared at the applicant’s request. The applicant claims that this report states that the adverse effects of cyanamide on the thyroid should be considered as non-specific secondary consequences of other toxic effects.
168 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, submits that the fifth plea in law must be rejected as inadmissible and, in any event, unfounded.
169 In that regard, it must be borne in mind that, under Article 21 of the Statute of the Court of Justice of the European Union and Article 76 of the Rules of Procedure, an application must indicate the subject matter of the proceedings and include a brief statement of the grounds relied on. The information given must be sufficiently clear and precise to enable the defendant to prepare his or her defence and the General Court to decide the case, if necessary, without other supporting information (judgment of 30 January 2007, France Télécom v Commission, T‑340/03, EU:T:2007:22, paragraph 166).
170 It should also be remembered that, even though the body of the application may be supported and supplemented, in regard to specific points, by references to extracts of documents appended thereto, the annexes have a purely evidential and instrumental function. The annexes cannot therefore serve as a basis for developing a plea set out in summary form in the application by putting forward complaints or arguments which are not contained in that application. The applicant must indicate in its application the specific complaints on which the Court is asked to rule and, at the very least in summary form, the legal and factual particulars on which those complaints are based (judgment of 30 January 2007, France Télécom v Commission, T‑340/03, EU:T:2007:22, paragraph 167).
171 In the present case, the applicant merely refers to a set of annexes to the application, reproduces them and briefly puts forward arguments used during the procedure for adopting the contested decision, without proffering the necessary clarifications for those arguments. The applicant fails to explain, in the body of its written pleadings, how the absence of the suggested studies and the neurotoxicity study should lead the Court to conclude that the Commission made a manifest error of assessment in finding that cyanamide had endocrine-disrupting properties.
172 Consequently, the applicant’s fifth plea in law must be rejected as inadmissible.
6. Sixth plea in law: manifest error of assessment by the Commission in finding in the contested decision that the BPC’s risk assessment supported the conclusion that cyanamide should not be approved
173 By its sixth plea in law, the applicant submits that the Commission made a manifest error of assessment in finding that the BPC’s risk assessment supported the conclusion that cyanamide should not be approved.
174 The sixth plea in law relied on by the applicant comprises two parts. Under the first part of its sixth plea, the applicant alleges that the BPC’s opinions of 30 November 2021, which were the basis for the contested decision’s approach to risk, do not constitute risk assessments. Under the second part of the sixth plea, the applicant submits that the Commission made a manifest error of assessment in applying a zero-risk approach through unrealistic exposure scenarios and the erroneous assessment of the degradation rate of cyanamide.
175 As is apparent from the discussion in paragraph 35 above, the rules governing biocidal products are aimed at improving the free movement of those products in the European Union, whilst guaranteeing a high level of protection for humans, animals and the environment. Moreover, as stated in paragraph 35 above, those rules are underpinned by the precautionary principle, so as to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in harmful effects on human or animal health or unacceptable effects on the environment. It follows therefrom that the contested decision, like any act adopted on the basis of those rules, is ipso jure based on the precautionary principle.
176 Furthermore, the application of the precautionary principle is not limited to cases in which it is uncertain that there is a risk; the principle may also be applied where a risk has been proven to exist and where the Commission must assess whether that risk is acceptable or not, or assess how it should be dealt with in a risk management context (judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 340).
177 Moreover, it follows from the precautionary principle that, where there is uncertainty as to the existence or extent of risks to the health of consumers, the institutions may take protective measures without having to wait until the reality and the seriousness of those risks become fully apparent (judgments of 22 December 2010, Gowan Comércio Internacional e Serviços, C‑77/09, EU:C:2010:803, paragraph 73, and of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43).
178 Within the process leading to the adoption by an institution of appropriate measures to prevent specific potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management 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 Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 111). Although the first of those stages does not require further explanation regarding the existence of proven risks beyond the existence of potential risks, the two subsequent stages call for clarification.
179 In the first place, assessment of the risks to public health, safety and the environment consists, for the institution required to consider potentially adverse effects arising from a phenomenon, in scientifically assessing those risks and in determining whether they exceed the level of risk deemed acceptable for society. Thus, in order for the institutions to be able to carry out a risk assessment, it is important for them, first, to have a scientific assessment of the risks and, secondly, to determine what level of risk is deemed unacceptable for society (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 137 and the case-law cited).
180 A scientific risk assessment is a scientific process consisting, in so far as possible, in the identification and characterisation of a hazard, the assessment of exposure to that hazard and the characterisation of the risk (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 138 and the case-law cited).
181 As a scientific process, the scientific risk assessment must be entrusted by the institution to scientific experts (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 115 and the case-law cited), must be based on the best scientific data available and must be undertaken in an independent, objective and transparent manner (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 117 and the case-law cited).
182 However, the scientific risk assessment is not required to provide the institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. A situation in which the precautionary principle is applied by definition coincides with a situation in which there is scientific uncertainty. Furthermore, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk, in so far as such proof is generally impossible to give in scientific terms since zero risk does not exist in practice. However, a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified (see, to that effect, judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 69 and the case-law cited).
183 In that regard, the responsibility for determining the level of risk which is deemed unacceptable for society lies, provided that the applicable rules are observed, with the institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on public health, safety and the environment and for the degree of those potential effects which, in their judgment, is no longer acceptable for society and above which it is necessary, in the interests of protecting public health, safety and the environment, to take preventive measures in spite of the existing scientific uncertainty (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 122 and the case-law cited).
184 In determining the level of risk deemed unacceptable for society, the institutions are bound by their obligation to ensure a high level of protection of public health, safety and the environment. That high level of protection does not necessarily have to be the highest that is technically possible, in order to be compatible with Article 114(3) TFEU (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 123 and the case-law cited).
185 The level of risk deemed unacceptable for society will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on public health, safety and the environment were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 124 and the case-law cited).
186 In the second place, risk management corresponds to the body of actions taken by an institution faced with a risk in order to reduce it to a level deemed acceptable for society having regard to its obligation, in accordance with the precautionary principle, to ensure a high level of protection of public health, safety and the environment (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 148).
187 It is in the light of those considerations that the sixth plea in law must be examined.
(a) First part of the sixth plea in law
188 The applicant argues that the BPC’s opinions of 30 November 2021, which were the basis for the contested decision’s approach to risk, do not constitute risk assessments. It follows that the Commission has not based its findings upon any risk assessment in reaching the contested decision.
189 In the first place, the applicant submits that the BPC’s opinions of 30 November 2021 do not constitute risk assessments given that the core data necessary for undertaking a risk assessment were absent. Those data include the neurotoxicity study and the absence of a conclusion on the other modalities, being the oestrogen, androgen and stereoidogenic modalities.
190 In the second place, the applicant argues that a credible risk assessment could not be undertaken because of the absence of guidance on how to conduct such an assessment.
191 In the third place, the applicant maintains that the risk assessment scenarios employed are not reflective of a realistic worst-case scenario.
192 In the fourth place, the Commission has not provided, in the contested decision, any credible explanation as to why no threshold can be set for cyanamide. In that regard, the applicant, referring to Professor Bridges’ report, argues that the toxicokinetics and the mode of action findings need to be taken together in considering whether, for cyanamide, there is a threshold for its adverse effects. As also recently reconfirmed by the European Food Safety Authority (EFSA), a monotonic dose-response relationship can be assumed in the case of enzymatic mechanisms implying that a threshold for adversity exists referring to, for example, TPO inhibition.
193 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, disputes the applicant’s arguments.
194 As stated in paragraph 86 above, the opinions of 10 December 2019 did not contain a risk assessment of the endocrine-disrupting properties of cyanamide.
195 Subsequently, the Commission adopted the mandate of 2 September 2020. Under that mandate, the Commission requested the BPC to evaluate the risks for human health and the environment posed by the endocrine-disrupting properties of cyanamide. In that context, the Commission specifically requested the BPC to specify the risk level for human health and the environment, using a quantitative or qualitative assessment, and to issue an opinion on whether or not that risk was acceptable.
196 It is apparent from the dossier that there was a debate amongst the BPC members about how that risk assessment was to be carried out.
197 As regards the risk level for human health, the evaluating competent authority proposed a quantitative risk assessment focused on the endocrine-disrupting properties of cyanamide, on the basis of available information. Nevertheless, a number of members disagreed with that approach, stating that, on the basis of available data, it was not possible to fix a reliable threshold because those parameters had not been evaluated. It was accordingly decided to use a qualitative assessment of secondary general public exposure to manure.
198 As regards the environmental risk assessment, the members agreed that it is currently impossible to derive safe thresholds for endocrine-disrupting properties of cyanamide for environmental non-target organisms. In fact, scientific opinions diverge on that question. Consequently, additional research and exchanges amongst scientists, regulators and industry were necessary before it was possible to decide on whether and how safety thresholds could be derived for cyanamide for environmental non-target organisms. It was accordingly decided to use a qualitative assessment of environmental exposure.
199 On that basis, in its opinions of 30 November 2021, the BPC carried out an analysis of cyanamide.
200 As regards the Commission’s request for a quantitative or qualitative assessment of the risks of cyanamide for human health, it follows from the BPC’s opinions of 30 November 2021 that a qualitative risk assessment was carried out on the basis of the description available for plant protection products, in the absence of harmonised exposure scenarios for the application of manure. In addition to exposure of professionals, exposure of the general public was taken into account. According to the BPC, none of the mitigating measures proposed made it possible to exclude the exposure of the general public. Due to the lack of threshold, the BPC concluded that it had not been possible to determine the risk level as part of the qualitative evaluation for the general public, whereas the risk associated with the endocrine-disrupting properties of cyanamide was considered acceptable for professional users.
201 As regards the Commission’s request for a quantitative or qualitative assessment of the risks of cyanamide for the environment, it follows from the BPC’s opinions of 30 November 2021 that a risk assessment in the strict sense of the term was not possible at that time for cyanamide. According to the BPC, it was not possible to proceed with a quantitative or qualitative assessment of the risks of cyanamide, given that there was no threshold to which exposure could be compared. The only option consisted in evaluating the exposure situation by placing particular emphasis on the question whether or not exposure could be considered negligible. The conclusion of that qualitative exposure assessment was that the information provided by the applicant on the natural presence of cyanamide in certain plant species did not allow for a reliable assessment of the natural occurrence and distribution of cyanamide in the environment and that releases of cyanamide into the environment resulting from intended uses of that substance could not be ruled out.
202 On the basis of those assessments of potential exposure of the general public and the environment to cyanamide, the BPC concluded that, due to the uncertainties surrounding the endocrine-disrupting properties of cyanamide, it was not possible to conclude that the risks for human health and the environment arising from the intended use of cyanamide were acceptable, whereas the risk for professional users was acceptable with adequate risk-mitigation measures.
203 It follows from the foregoing that the BPC did conduct a risk assessment on the basis of an examination of the types and degrees of exposure and also potential risk-mitigation measures.
204 The applicant does not dispute that the BPC carried out an examination of the risks of cyanamide as regards the risk of endocrine disruption for human health, although it does argue that that evaluation is incorrect. At the same time, the applicant submits that the BPC did not carry out any assessment of the risks for the environment. In support of that argument, the applicant merely observes that, in the BPC’s opinions of 30 November 2021, it is stated that no assessment of the risks for the environment was carried out as regards the endocrine-disrupting properties of cyanamide.
205 In that regard, the Court finds that the BPC’s opinions of 30 November 2021 merely indicate that an assessment of the risks of cyanamide in the strict sense of the term could not be carried out for the environment. That wording does not in itself support a conclusion that the evaluation of exposure arising from the use of cyanamide was not equivalent to a qualitative risk assessment satisfying the requirements of point 3 of Annex VI to Directive 98/8. In that context, it should be noted that it is apparent from part 2.3 of the BPC’s opinions of 30 November 2021 on the application for approval of cyanamide that the lack of threshold made it impossible to establish a quantitative assessment of cyanamide risk, but that a qualitative risk assessment shows that exposure resulting from the use of cyanamide cannot be ruled out.
206 In the light of the foregoing, the applicant’s argument to the effect that, in the BPC’s opinions of 30 November 2021, it is stated that no assessment of the risks for the environment was carried out as regards the endocrine-disrupting properties of cyanamide, must be rejected.
207 Moreover, the fact that the BPC’s opinions of 30 November 2021 do not examine whether or not the risk of cyanamide for human health and the environment is acceptable does not change the fact that a risk assessment was carried out in those opinions. The BPC merely refrained from making a statement as to whether or not the risk identified was acceptable.
208 In the applicant’s argument to the effect that the BPC could not reliably carry out an assessment of the risk of endocrine disruption, given that the core data, that is to say, the neurotoxicity study and the conclusion on the oestrogen, androgen and stereoidogenic modalities, were lacking, the applicant fails to explain why that information was necessary for carrying out such an assessment. In fact, the applicant merely refers to a number of points in that part of the application relating to the legal context and facts of the present case. Those points do not explain why the information in question is necessary for carrying out an assessment of the risks of cyanamide.
209 In those circumstances, the Court finds that the applicant has failed to demonstrate that the Commission made a manifest error of assessment in carrying out a risk assessment without the neurotoxicity study and without a conclusion on the oestrogen, androgen and stereoidogenic modalities. Moreover, allowing the applicant to carry out those studies had the potential to make the procedure considerably more protracted, without any certainty that they would have led to a finding of a safe threshold for cyanamide. Extending the procedure in this manner is not compatible with the objective of maintaining a high level of protection for human and animal health and the environment.
210 As to the applicant’s argument to the effect that it is not possible to carry out a risk assessment without guidance as to how to proceed with such an assessment, it is clear that neither Directive 98/8 nor Regulation No 528/2012 requires or presupposes that a risk assessment must be prepared in accordance with a guide or recommendations.
211 It is true, however, that the risk assessment conducted by the BPC was not based on a guidance document. It is also true that, at a meeting of the BPC, the evaluating competent authority referred to the absence of guidance as being one of the reasons for why the risk assessment was inconclusive.
212 A guidance document generally contains the protection goals, as set by the risk manager, and the substantive assessment criteria (assessment schemes and actual numerical values the attainment of which leads to non-approval, etc.) necessary for the evaluation of those protection goals (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 241).
213 In that regard, the Court finds that the Commission stated that ECHA was unable to develop guidance for risk assessment of endocrine disruptors, as that required more experience. It follows that although the risk assessment for cyanamide ought to have been based on a guidance document, it would have potentially been necessary to postpone indefinitely the assessment of the risks of that active substance.
214 In those circumstances and in view of the Commission’s margin of discretion in the area, it is clear that the Commission did not make a manifest error of assessment in basing the contested decision on a risk assessment that was not based on a guidance document. In that regard, the Court notes that it would not have been compatible with the objective of maintaining a high level of protection for human and animal health and the environment for the Commission to postpone the decision on approval of cyanamide until such a guidance document had been prepared. On the contrary, it was for the Commission, acting under the precautionary principle, to adopt protective measures without having to wait for the seriousness of the risks, highlighted by the BPC’s opinions of 30 November 2021, to be fully demonstrated.
215 Consequently, the complaint alleging that the risk assessment was not based on a guidance document must be rejected.
216 In support of its argument to the effect that the risk assessment scenarios employed are not reflective of a realistic worst-case scenario, the applicant merely refers to a quote from Professor Bridges’ report, which notes that pig excreta may contain pathogens as well as many other chemicals, and that exposure to those substances constitutes a substantial risk to health. Hence, since manure containing cyanamide already poses a risk for human health, it is not realistic to suppose that there is a risk of human exposure to cyanamide due to use of liquid manure in fields.
217 Referring to Professor Bridges’ report, the Court finds that the applicant has not discharged its burden of proving nor adduced the evidence required to establish that the risk assessment scenarios employed in the BPC’s opinions lack credibility. The fact that cyanamide-treated manure may potentially pose a health risk for reasons other than the presence of cyanamide does not rule out the possibility that persons may be exposed to manure if they enter a field where it has been used.
218 Lastly, as regards the applicant’s argument to the effect that the Commission failed to provide a plausible explanation for why no safe threshold could be fixed for cyanamide, it should be borne in mind, as stated in paragraphs 197 and 198 above, that the reasons underpinning why such a threshold cannot be established differ depending on whether the effects are on human health or the environment.
219 The assessment of risks for human health concerned the lack of information on other endocrine-disrupting modes, whilst the assessment of risks for the environment concerned diversity of non-target organisms and a lack of suitable testing methods.
220 The applicant has failed to demonstrate that that analysis is manifestly incorrect.
221 The applicant merely disputes the Commission’s argument, put forward in paragraph 143 of its defence, to the effect that there is currently no scientific consensus on the possibility for determining a threshold for the endocrine-disrupting properties in every case, given that endocrine-disrupting effects can be manifested even at very low dose and, in some cases, effects are even stronger at lower concentrations than at higher ones. According to the applicant, a dose-response relationship can be assumed for cyanamide.
222 The applicant submits that that finding is confirmed by EFSA in a report of November 2023.
223 In the report referred to in paragraph 222 above, EFSA set a threshold for thiophanate-methyl, which has endocrine-disrupting properties. According to EFSA, since the endocrine disruption effects observed for the thyroid are based mainly on hepatic enzyme induction, a dose-response relationship can be assumed to be monotonic.
224 Nevertheless, in the present case, the endocrine-disrupting effects observed for the thyroid are not based on hepatic enzyme induction, but rather on TPO inhibition. The Court accordingly finds that EFSA’s reasoning concerning thiophanate-methyl cannot be transposed to the facts of the present case in regards to cyanamide.
225 In the light of the foregoing, the applicant has failed to establish that the Commission made a manifest error of assessment in finding that it was not possible to set safe thresholds for cyanamide and has failed to adduce sufficient evidence to render implausible the assessments and facts on which the contested decision is based.
226 It follows that the first part of the sixth plea in law must be rejected.
(b) Second part of the sixth plea in law
227 The applicant submits that, if the BPC’s opinions of 30 November 2021 were to constitute risk assessments, as required by Regulation No 528/2012, the Commission made manifest errors of assessment in adopting the contested decision, inter alia in applying a zero-risk approach through unrealistic exposure scenarios and in making an erroneous assessment of the degradation rate of cyanamide.
228 In the first place, the applicant argues that the exposure scenario models that were ultimately used were based on plant protection product uses, rather than biocides. According to the applicant, the exposure scenarios for plant protection products and biocides have several fundamental differences. In view of those differences, particularly the exposure scenario whereby vulnerable populations would be subject to secondary exposure in fields on which liquid manure has been distributed is highly unlikely.
229 In the second place, the applicant submits that the risk assessment erred in assuming an excessively slow degradation rate of cyanamide. Indeed, the study by Voelkel e.a. from 2007 (‘the Voelkel study’), relied upon for risk assessment, cannot be considered reliable, in particular because a more recent study by Kreuzig e.a. from 2010 (‘the Kreuzig study’), which the applicant submitted during the approval procedure, showed that the actual degradation rate is faster. This actual degradation rate means that, at the time when the liquid manure is distributed on the field, the cyanamide will no longer be detectable in the manure, due to its fast degradation.
230 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, disputes the applicant’s arguments.
231 As regards the applicant’s first complaint, the Court finds that, in its opinions of 30 November 2021, the BPC evaluated potential exposure of the general public to cyanamide following the application of liquid manure to agricultural land. Those exposure scenarios are based on the intended use of cyanamide, which is applied once or twice a year to liquid manure, after which the liquid manure is used for crop manuring or applied to agricultural land. Moreover, as there was no agreed methodology for assessment of the risks of endocrine-disrupting properties and no available model for the application of manure, exposure was described on the basis of exposure scenarios drawn up for the application of plant protection products.
232 The applicant argues that the exposure scenarios employed in the BPC’s opinions of 30 November 2021 are highly unlikely, given that exposure scenarios for plant protection products and biocides have three differences.
233 In the first place, the applicant submits that cyanamide, used as a biocidal product, is put into the soil (in the manure) rather than sprayed onto the surface.
234 In that regard, it is clear that the applicant has not adduced any evidence establishing that putting manure into the soil means that there is no hazard for persons in proximity to places where the manure is distributed.
235 In the second place, the applicant submits that the size of droplets dispersed is different (because of differing nozzle spray size) and therefore distribution is different.
236 The applicant has not elaborated on that argument. It has failed to explain why the fact that the distribution of cyanamide in the manure is different from that of plant protection products makes the exposure scenarios employed by the BPC in its opinions of 30 November 2021 unlikely.
237 In the third place, the applicant observes that the foul odour of manure makes secondary contact (from non-professionals) far less likely, since there is a natural aversion to contact.
238 In that context, the Court finds that the possibility cannot in any event be ruled out that, despite a foul odour, persons may come close to a field where manure containing cyanamide has been distributed. Nor has the applicant indicated the duration of that foul odour.
239 In the light of the foregoing, the applicant has failed to provide sufficient evidence to render implausible the factual assessments on which the contested decision is based, in particular the exposure scenarios employed in the BPC’s opinions of 30 November 2021.
240 As regards the applicant’s second complaint, relating to the rate of degradation of cyanamide, the applicant does not dispute that the rate of degradation is based on the Voelkel study, which it submitted itself. Both the evaluating competent authority and the BPC’s Working Group for ‘Environment’ used that study for the evaluation of cyanamide.
241 It is also not disputed that the applicant provided the Kreuzig study only on 20 August 2021 and that the evaluating competent authority had not requested that study.
242 In that regard, it should be borne in mind that it is the person seeking approval who must prove that the conditions of such approval are met in order to obtain it, and not the Commission that must prove that the conditions of approval are not met in order to be able to refuse it (see, to that effect, judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraphs 86 and 88).
243 In view of that allocation of the burden of proof, where an applicant considers that new data or studies, submitted after his or her dossier has been validated, should have been taken into account for the evaluation of the substance at issue, it is for that applicant to demonstrate that such data or studies could not be submitted before his or her dossier was validated, that they are necessary and that they manifestly call into question the outcome of the evaluation procedure (judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 178).
244 The Kreuzig study dates from 2010. Nevertheless, the applicant fails to explain why that study could not be provided earlier. It is accordingly clear that the evaluating competent authority was not required to examine the Kreuzig study in its assessment of cyanamide.
245 Moreover and in any event, even if the Kreuzig study had actually been provided to the evaluating competent authority in a timely manner, it does not establish to the requisite legal standard that the Commission made a manifest error of assessment in the evaluation of the rate of degradation of cyanamide.
246 As confirmed by the applicant, the Commission does not dispute that the Kreuzig study found that that the degradation rate of cyanamide was faster than what was stated in the Voelkel study.
247 Nevertheless, as noted in paragraph 36 above, EU authorities must be allowed a certain margin of discretion in the evaluation of scientific studies and the choice of which are to prevail over others, irrespective of their chronology (judgment of 24 October 2018, Deza v Commission, T‑400/17, not published, EU:T:2018:712, paragraph 57). Hence, it was not sufficient for the applicant to rely on the fact that the Voelkel study was older in order to call its reliability into question. It still had to provide sufficiently precise and objective indicia supporting a contention that possible recent scientific developments called into question the well-foundedness of that study and, consequently, that of the disputed rate of degradation.
248 There are no such indicia in the present case. In merely referring to a more recent study, the applicant has failed to provide such indicia. In that regard, it is clear that the applicant has failed to adduce any evidence of the alleged lacunae in the Voelkel study, which it submitted to the evaluating competent authority itself.
249 In the light of the foregoing, the applicant’s complaint to the effect that, at the time when the liquid manure is distributed on the field, the cyanamide will no longer be detectable in the manure due to its fast rate of degradation, must be rejected.
250 Consequently, the second part of the sixth plea in law must be rejected, as must therefore the sixth plea in law in its entirety.
7. Eighth plea in law: infringement of the principle of proportionality
251 By the eighth plea in law, the applicant submits that, in adopting the contested decision while disregarding more suitable and proportionate options, the Commission infringed the principle of proportionality. According to the applicant, five lawful alternatives to the non-approval existed, which would have been more suitable and proportionate in the circumstances of this specific case.
252 The first option could have been to grant an approval for product-types 3 and 18. The second option could have been to grant an approval subject to the fulfilment of a confirmatory data submission condition as part of the subsequent product authorisation procedure. The third option could have been the submission of data, either as post-approval data as part of the active substance approval or as a data requirement for renewal. The fourth option could have been to refer the matter back to the BPC for further consideration. The fifth option could have been approval incorporating a condition as to the adoption and application of restrictions by the Member States on liquid manure application.
253 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, disputes the applicant’s arguments.
254 According to settled case-law, the principle of proportionality, which is one of the general principles of EU law, requires that measures adopted by EU institutions must not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question; where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 279 and the case-law cited).
255 It should also be borne in mind that the Commission has broad discretion for the purposes of adopting risk-management measures involving political choices and complex scientific assessments. Consequently, it is only when a measure adopted in that area is manifestly disproportionate, having regard to the objective the Commission intends to pursue, that that measure’s lawfulness may be affected (see, to that effect, judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 289 and the case-law cited).
256 In the present case, first, as regards the applicant’s first complaint, to the effect that the Commission could have granted an approval for cyanamide for product-types 3 and 18, it is apparent from the examination of the applicant’s fifth and sixth pleas in law (see paragraphs 165 to 250 above) that it has not been established that the Commission made a manifest error of assessment in finding, in recitals 13 to 15 of the contested decision, that the applicant had failed to demonstrate, on the basis of the data available in the application submitted for the approval, that the conditions for approval of cyanamide were satisfied.
257 Secondly, as regards the second and third complaints, the applicant submits that the Commission could have opted for other approaches having less serious consequences, such as approving cyanamide subject to the fulfilment of a confirmatory data submission or authorising the submission of data, either as post-approval data or as a data requirement for renewal, rather than adopting a decision not to approve cyanamide.
258 In that regard, in the first place, it is clear that the applicant has not indicated to which confirmatory data and post-approval data it is referring in the two complaints.
259 In the second place and in any event, the Court notes that the solutions proposed by the applicant under the second and third complaints are tantamount to approval of cyanamide subject to conditions. Consequently, as correctly observed by the Federal Republic of Germany, those solutions presuppose that the risk is acceptable and that the criteria for the approval of cyanamide are satisfied. Nevertheless, as stated in paragraph 256 above, the applicant has failed to demonstrate that the Commission made a manifest error of assessment in finding that the conditions for the approval of cyanamide were not fulfilled in the present case.
260 Thirdly, as regards the option consisting in referring the case to the BPC for drawing up guidance that is still lacking, reference is made to paragraphs 210 to 215 above, concerning the alleged manifest error of assessment made by the Commission in basing the contested decision on a risk assessment that was not based on a guidance document. As stated in paragraph 214 above, it would not have been compatible with the objective of maintaining a high level of protection for human and animal health and the environment for the Commission to postpone the decision on approval of cyanamide until such a guidance document had been prepared.
261 Fourthly, as regards potential approval of cyanamide subject to a condition relating to the adoption and application of restrictions laid down by Member States governing the application of manure, as correctly observed by the Commission, it is clear that Regulation No 528/2012 does not empower the Commission to impose, as a condition of approval of an active substance, an order addressed to the Member States laying down the rules they are to adopt or apply in their national legislation relating to the distribution of livestock manure on agricultural land. Moreover and in any event, the applicant has failed to demonstrate that restrictions on the application of manure would entail an acceptable risk for human and animal health.
262 In the light of the foregoing, the applicant has failed to establish to the requisite legal standard that the adoption of the contested decision constitutes an infringement of the principle of proportionality.
263 Consequently, the applicant’s eighth plea in law must be rejected.
8. The other pleas in law put forward by Industrieverband Agrar
264 Industrieverband Agrar puts forward four additional pleas in law.
265 In the first place, Industrieverband Agrar submits that the Commission has infringed Article 5(1)(b)(iii) and (iv) of Directive 98/8, read in conjunction with Article 10(1) of that directive, by failing to evaluate all relevant information when assessing whether cyanamide has unacceptable effects on human health or the environment. According to Industrieverband Agrar, the Commission ought to have examined whether the factual elements listed in Article 5(2) of Regulation No 528/2012 made it possible to approve cyanamide even though it had been found to have endocrine-disrupting properties.
266 In the second place, Industrieverband Agrar submits that, by failing in the context of the cyanamide assessment to assess all factual elements, in particular those enshrined in Article 5(2) of Regulation No 528/2012, the Commission infringed the applicant’s right to a complete and impartial examination.
267 In the third place, Industrieverband Agrar submits that the contested decision infringes the principle of proportionality enshrined in Article 52(1) of the Charter of Fundamental Rights. First, when the Commission assessed the risks associated with cyanamide, it failed to consider any beneficial factors supporting the approval of cyanamide, such as the lack of alternatives and any potential disproportionate impact of non-approval, and weigh them against the existence of endocrine-disrupting properties. Second, the Commission omitted to engage at all with an evaluation of whether any risk mitigation measures could, as measures less onerous than a non-approval, reduce the risks incurred by the use of cyanamide to an acceptable level. In particular, the Commission failed to consider whether cyanamide could be approved under the condition that any subsequent authorisations of biocidal products containing cyanamide should only be granted where the cyanamide product was in line with the factors now enshrined in the derogation factors listed in Article 5(2) of Regulation No 528/2012.
268 In the fourth place, Industrieverband Agrar submits that, even assuming that the Commission had assessed the factual elements now enshrined in the derogation factors listed in Article 5(2) of Regulation No 528/2012 when assessing cyanamide, it infringed its duty to state reasons established in Article 296 TFEU as it failed to state the grounds relating to those assessments in the contested decision.
269 The Commission, supported by the Federal Republic of Germany, the Republic of Lithuania and ECHA, submits that the additional pleas in law put forward by Industrieverband Agrar must be rejected as inadmissible and, in any event, unfounded.
270 In that regard, it should be borne in mind that, whilst the fourth paragraph of Article 40 of the Statute of the Court of Justice, applicable to the procedure before the General Court by virtue of the first paragraph of Article 53 of that statute, and Article 142(3) of the Rules of Procedure do not preclude the intervener from advancing arguments which are new or which differ from those of the party he or she supports, lest his or her intervention be limited to restating the arguments advanced in the application, it cannot be held that those provisions permit him or her to alter or distort the context of the dispute defined in the application by raising new pleas in law (see judgment of 12 December 2006, SELEX Sistemi Integrati v Commission, T‑155/04, EU:T:2006:387, paragraph 42 and the case-law cited).
271 In other words, those provisions give the intervener the right to set out arguments as well as pleas independently, in so far as they support the form of order sought by one of the main parties and are not entirely unconnected with the issues underlying the dispute, as established by the applicant and defendant, as that would otherwise change the subject matter of the dispute (judgments of 15 June 2005, Regione autonoma della Sardegna v Commission, T‑171/02, EU:T:2005:219, paragraph 152, and of 2 October 2009, Cyprus v Commission, T‑300/05 et T‑316/05, not published, EU:T:2009:380, paragraph 203).
272 In the present case, the dispute, as established by the applicant and the Commission, concerns the annulment of the contested decision. The parameters of the dispute are delimited by the forms of order sought and the eight pleas in law put forward by the applicant, alleging: (i) infringement of Article 90(2) of Regulation No 528/2012; (ii) infringement of Delegated Regulation 2017/2100; (iii) infringement of the applicant’s rights of defence; (iv) infringement of the applicant’s legitimate expectations; (v) manifest error of assessment resulting from the Commission’s conclusion that cyanamide is a substance having endocrine-disrupting properties; (vi) manifest error of assessment by the Commission in concluding that the BPC’s risk assessment supported the conclusion in the contested decision that cyanamide must not be approved; (vii) infringement of the principles of equal treatment and non-discrimination; and (viii) infringement of the principle of proportionality.
273 The additional pleas in law put forward by Industrieverband Agrar are all based on the premiss that the contested decision is vitiated by an additional, autonomous error of law, inasmuch as the Commission omitted to take account of the factors now enshrined in Article 5(2) of Regulation No 528/2012 in assessing whether cyanamide had unacceptable effects on human health or the environment.
274 Nevertheless, neither the application nor the defence contains anything concerning the need to apply the derogation factors listed in Article 5(2) of Regulation No 528/2012. Under the first plea in law, the applicant submits that the Commission infringed the transitional rules laid down in Article 90(2) of Regulation No 528/2012, inasmuch as it applied the criteria laid down in Article 5 thereof instead of the criteria laid down in Directive 98/8. Consequently, as correctly observed by the Commission, the intervener’s assertion concerning the need to apply the derogation factors listed in Article 5(2) of Regulation No 528/2012 is contrary to the applicant’s, which criticised the Commission for having taken them into account.
275 It follows that the four additional pleas in law put forward by Industrieverband Agrar are not connected to the subject matter of the dispute as defined by the main parties and thus alter the framework of the present dispute. Those pleas must accordingly be dismissed as inadmissible.
276 In the light of all the aforementioned considerations, the action must be dismissed.
B. The application for measures of organisation of procedure
277 By document lodged at the Court Registry on 25 August 2023, the applicant asked the Court to adopt measures of organisation of procedure, in accordance with Article 89(3)(d) of the Rules of Procedure of the General Court, ordering the Commission to produce a number of documents relating to the correspondence between the Directorate-General for Health & Food Safety (DG SANTE) and the Commission’s Legal Service in the context of the preparation of the contested decision, consisting in the draft contested decision comprising the suggestions and comments of the Legal Service, proposed amendments and related comments from DG SANTE, as well as a cover email from the Commission’s Legal Service to DG SANTE.
278 In that regard, it has consistently been held that it is for the Court to appraise the usefulness of measures of organisation of procedure and measures of inquiry (see, to that effect, judgment of 9 March 2015, Deutsche Börse v Commission, T‑175/12, not published, EU:T:2015:148, paragraph 417 and the case-law cited).
279 When a request for production of documents, put forward by a party, specifies the grounds justifying such a measure, it is for the Court to assess the relevance of that request in relation to the subject matter of the dispute and the need to proceed with 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).
280 However, there is no need to order a measure of organisation of procedure sought by an applicant where its purpose is not to clarify the plea the applicant raised or to prove that its factual submissions are accurate, but rather appears to be an attempt to obtain new evidence in support of its action, unless the applicant raises specific complaints which can be checked or clarified by a request for information or for specific documents (see, to that effect, judgment of 11 July 2019, BP v FRA, T‑838 /16, not published, EU:T:2019:494, paragraph 411 and the case-law cited).
281 In the present case, the applicant has not indicated specifically why potentially producing the documents at issue was justified.
282 In that regard, the Court notes that it is common ground amongst the parties that the documents at issue contain only information relating to the legal positions adopted by the Commission’s services on the lawfulness of different options envisaged during the process of drawing up the contested decision. Therefore, the documents at issue do not form the factual substratum of the Commission’s exercise of its powers, as they do not contain factual or scientific considerations that served as a basis for the adoption of the contested decision. The production of those documents is accordingly not capable of enabling the applicant to clarify its complaints or prove the veracity of its allegations in the pleas in law it has put forward.
283 In any event, it should be noted that the Court has been duly able to rule on the basis of the forms of order sought, the pleas in law and arguments put forward in the course of the proceedings and in the light of the documents lodged by the parties.
284 It follows that the application for measures of organisation of procedure must be dismissed.
285 Therefore, in the light of all the aforementioned considerations, the action must be dismissed in its entirety.
IV. Costs
286 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.
287 Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission.
288 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. Under Article 1(2)(g) 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, which may be parties before the General Court. According to Article 100 of 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), ECHA is a body of the European Union. The Federal Republic of Germany, the Republic of Lithuania and ECHA shall therefore each bear their own costs.
289 Lastly, under Article 138(3) of the Rules of Procedure, the Court may order an intervener other than those referred to in paragraphs 1 and 2 of that article to bear its own costs. In the present case, Industrieverband Agrar, which intervened in support of the form of order sought by the applicant, is to bear its own costs.
On those grounds,
THE GENERAL COURT (Sixth Chamber)
hereby:
1. Dismisses the action.
2. Orders AlzChem Trostberg GmbH to bear its own costs and to pay those incurred by the European Commission.
3. Orders Industrieverband Agrar eV, the Federal Republic of Germany, the Republic of Lithuania and the European Chemicals Agency (ECHA) to bear their own costs.
Delivered in open court in Luxembourg on 3 December 2025.
V. Di Bucci | | M. van der Woude |