Judgment;Abstract — ECLI:EU:T:2025:1087
Date: 2025-12-03
Language of the case: English
Court formation: Sixth Chamber
Procedure: Action for annulment
Origin: Germany

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. Costeira Öberg Zilgalvis Delivered in open court in Luxembourg on 3 December 2025. V. Di Bucci M. van der Woude Registrar President * Language of the case: English.