Judgment;Information — ECLI:EU:T:2021:688
Date: 2021-10-13
Language of the case: English
Court formation: First Chamber
Subject matter: Agriculture and Fisheries;Plant health legislation
Procedure: Action for annulment - unfounded
Origin: United Kingdom

summary of a book by the Society of Environmental Toxicology and Chemistry, published in 2007 and entitled Assessing the Hazard of Metals and Inorganic Metal Substances in Aquatic and Terrestrial Systems, which resulted from discussions that took place during a workshop held from 3 to 8 May 2003 and draws conclusions from that workshop on the possibility of developing a model that makes it possible to assess the hazards represented by metals better, highlighting the unsuitability of the persistence criterion in respect of inorganic substances. 83 Although, in the absence of the full version of that book, it cannot be concluded with certainty that it actually supports the applicant’s position, the probative value of the document produced can, in any event, be assessed in the light of the examination of another document provided by the applicant, namely an article published in 2007 in the scientific journal Environmental Toxicology and Chemistry, entitled ‘Can the unit world model concept be applied to hazard assessment of both organic chemicals and metal ions?’. Although it is clear from that document that the persistence criterion may pose certain difficulties when applied to the hazard assessment of inorganic substances, it cannot, in contrast, be inferred from this that there is a scientific consensus to the effect that it is meaningless to apply the PBT criteria to inorganic compounds. First of all, the subject matter of the article is whether it is possible to apply another approach, to both organic and inorganic substances. Next, the approach advocated in that article appears to reveal that an alternative model is potentially conceivable, but that it is not free from difficulties in its application. Lastly, it is not apparent that the persistence criterion is completely rejected in that model, but that it is simply integrated with other criteria. 84 In the light of that article, it therefore appears that the remarks made in the Society of Environmental Toxicology and Chemistry’s book as summarised in the document annexed to the application, which are implicitly referred to in the article in the Environmental Toxicology and Chemistry journal, reflect merely the expression by a certain number of scientists of the need to find a more appropriate method for assessing the hazards of metals. 85 Second, the applicant relies on a document entitled Metals Environmental Risk Assessment Guidance published in January 2007 by the International Council on Mining & Metals (ICMM). The applicant has extracted a passage indicating, generally, that because the majority of the compounds assessed are organic substances rather than inorganic metals, the various methodologies and guidance documents provided for performing those assessments are lacking in detail on how to account for metal-specific attributes. However, that document concerns, in essence, the criterion of bioaccumulation and not the unsuitability of the persistence criterion. Since the bioaccumulation criterion was not taken into account in classifying copper compounds as CFS, that document cannot support the demonstration of the existence of the consensus the proof of which is sought. Furthermore, as the Commission, the Parliament and the Council point out, that document does not have indisputable probative value, since it was drawn up by two sectoral associations and a private undertaking, the independence of which has not been established in the present case. 86 Third, the applicant has submitted a guidance document from the European Centre for Ecotoxicology and Toxicology of Chemicals (Ecotoc), published in July 2014. That document concerns the information to be taken into consideration in the evaluation of the PBT criteria and the criteria relating to very persistent and very bioaccumulative substances applicable to chemicals falling within the scope 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). Contrary to what the applicant appears to claim, the fact that that document does not change the field of application of the PBT criteria is insufficient to demonstrate the existence of a consensus as to the non-applicability of the criterion of persistence to inorganic substances, since that issue is not specifically addressed in that document. 87 Moreover, the same observations as those relating to the relevance of the Ecotoc document in the present case may be made in relation to the European Chemicals Agency (ECHA) Guidance on Information Requirements and Chemical Safety Assessment of June 2017, which the applicant also submits in support of its position. 88 In the second place, it may be noted that the applicant has failed to demonstrate convincingly that it is apparent from the approach followed in other countries that there was consensus within the scientific community and among the competent legislative bodies. 89 In that regard, first, it should be noted that the slide to which the applicant refers in order to illustrate its comments, in the reply, provides no explanation with regard to the legislative texts adopted around the world that it merely lists. Second, and similarly, in its observations on the Parliament’s statement in intervention, the applicant merely asserts that the only piece of legislation within the European Union, and even worldwide, that applies the PBT criteria (with particular attention to the persistence criterion) to inorganic compounds, such as copper compounds, is Regulation No 1107/2009. Third, the alternative model discussed in the documents referred to in paragraphs 82 and 83 above dates from 2007. Moreover, nothing indicates that it has been implemented since then, even though it was developed by a multi-disciplinary and international group of 47 scientists, managers and political decision-makers from Europe, Canada and the United States. 90 In the light of the foregoing, although it may be accepted that there is a debate as to the relevance of applying the persistence criterion in the context of the assessment of the hazards of inorganic substances, it cannot however be concluded that the applicant has adduced evidence that that criterion was inapplicable or that there was consensus within the scientific community in that regard. The most relevant documents in that regard do not demonstrate that failing to include inorganic substances in the context of assessments applying the PBT criteria was the scientific standard that the legislature should have taken into account when adopting Regulation No 1107/2009, but relate, above all, to research for a method more suited to the specific characteristics of those substances which enable their hazards – the existence of which is in no way excluded – to be better identified (see, in that regard, paragraphs 82 to 84 above and paragraphs 110 and 111 below). 91 As a result, by failing to adduce evidence demonstrating the existence of that consensus, the applicant has not proved to the requisite legal standard that there was a manifest error of assessment on the part of the legislature as a result of its failure to exclude inorganic substances from the scope of the assessment applying the PBT criteria in Regulation No 1107/2009 at the time when that regulation was adopted. (2) Recognition that the application of the PBT criteria to inorganic substances is inappropriate having regard to the positions adopted by EFSA, SCoPAFF and the DG for Health and Consumers 92 The applicant asserts that EFSA, SCoPAFF and the DG for Health and Consumers have recognised that the guidelines on the risk assessment of metals are inappropriate with regard to copper compounds. 93 It observes, first of all, that, in its conclusion of 20 December 2017 on the peer review of the pesticide risk assessment of copper compounds, EFSA states that the available data were not sufficient to take into account fully the specific nature of copper in the context of the environmental risk assessment and that the available guidance in the area of pesticide active substance environmental risk assessment does not specifically cover metal compounds. 94 It notes, next, that, in its final renewal report for the active substances copper compounds, SCoPAFF specifically mentions the need for EFSA to develop a new methodology that takes into account the available methodology applied in other areas by the ECHA. 95 Lastly, it states that, in its letter of 13 February 2019, the DG for Health and Consumersinstructed EFSA to develop new guidance, stating that the guidance documents available regarding environmental risk assessment of pesticides are not always directly applicable to those metal compounds because, inter alia, metal compounds are already present in the environment at varying levels, either appearing naturally or in different sources. It also claims that the DG for Health and Consumers is calling for a consistent approach across all EU legislation. 96 In the first place, although, as the applicant points out, those documents reveal a certain awareness, at the level of certain EU authorities, of the need to improve the methodology for the risk assessment of copper, that awareness does not amount to recognition by those authorities of the inappropriateness of the PBT criteria for assessing the hazards posed by inorganic substances, let alone to demonstrating the existence of evidence which enables identification of a manifest error of assessment committed by the legislature at the time Regulation No 1107/2009 was adopted. 97 In the second place, it should be noted that, although the EFSA document refers to the fact that the available guidance in the area of pesticide active substance environmental risk assessment does not specifically cover metal compounds, it nevertheless states that the available data on copper compounds were assessed and considered for their merits in the light of the methodologies and knowledge available at the time taking into considerations the specific characteristics of copper. 98 In the third place, the documents submitted by the applicant concerning risk assessment methodologies which, as the applicant itself explains in the reply and in its observations on the Parliament’s statement in intervention, depend on the intended uses, may therefore vary according to the regulated field, as the applicant concedes in the reply. Therefore, the fact that EFSA and ECHA follow different methods is irrelevant in the context of the applicant’s argument that the methods for assessing the hazards of inorganic substances must be consistent because the intrinsic properties of those substances are identical. 99 In the fourth place and in any event, the legislature’s decision not to exclude inorganic substances from the scope of application of the assessment applying the PBT criteria dates from the adoption of Regulation No 1107/2009 on 21 October 2009. No position capable of reflecting with certainty a state of scientific knowledge at the relevant time that supports the applicant’s claim, in the context of which the Court’s review must be carried out in the context of the first plea, is apparent from any of the documents. 100 Consequently, while it may be accepted that it is apparent from the EFSA, SCoPAFF and DG for Health and Consumers documents on which the applicant relies that the relevance of the application of the PBT criteria in respect of inorganic substances is under discussion, it must nevertheless be noted that the applicant has not provided sufficient evidence to support the conclusion that the non-applicability of the PBT criteria to inorganic substances was the scientific standard when Regulation No 1107/2009 was adopted. 101 In addition, as the Parliament notes in its observations on the applicant’s additional observations, beyond the mere existence of a debate on the inappropriateness of applying the PBT criteria to inorganic substances, the series of assessments and procedures to which copper compounds were subjected in order to obtain their approval and the renewal of that approval shows in itself that there was no scientific consensus on the issue. 102 Therefore, by failing to adduce evidence demonstrating the existence of a consensus, at the time Regulation No 1107/2009 was adopted, as to the non-applicability of the PBT criteria to inorganic substances, and so that that alleged non-applicability constituted the scientific standard, the legislature did not commit any manifest error of assessment for having applied the PBT criteria to copper compounds. 103 In the light of the foregoing, the first part of the first plea must be rejected as unfounded. (b) The second part of the first plea: application of the PBT criteria to inorganic substances under Regulation No 1107/2009 is inconsistent with other regulatory acts implemented in the same field before and after Regulation No 1107/2009 104 The applicant submits that it is apparent from the Commission document entitled ‘Questions and Answers on Candidates for Substitution’, dating from January 2015, that the PBT criteria contained in point 4 of Annex II to Regulation No 1107/2009 are used to assess the intrinsic properties of substances. It points out that, by definition, the intrinsic properties of a substance do not vary depending on its use. Thus, any legislation, where it relates to the intrinsic properties of a substance, should reflect that constancy. However, the applicant is of the view, in essence, that its analysis of the EU legislation does not result in such a finding, in so far as inconsistencies are apparent with regard to Regulation No 1907/2006, 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), to Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ 2003 L 304, p. 1) and to Commission Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation No 1107/2009 as regards the criteria for the approval of low-risk active substances (OJ 2017 L 205, p. 59). 105 The applicant asserts that the intrinsic properties of a substance should be subject to the same hazard assessment criteria across legislative frameworks and thus irrespective of what the subsequent use of the active substance will be, since, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation No 1907/2006 (OJ 2008 L 353, p. 1), it is necessary to harmonise as far as possible all hazard assessments based on intrinsic properties. 106 In the first place, in so far as the applicant alleges an infringement of EU law by reason of the application of the PBT criteria to inorganic substances under Regulation No 1107/2009 being inconsistent with other legislative acts implemented in the same field before and after that regulation, it is sufficient to note that there is no obligation on the legislature to harmonise the approaches followed in different regulatory frameworks. Recognition of the need to adopt a coherent approach, on which the parties agree, does not create a legal obligation and still less an ipso facto ground of illegality of an act. 107 Similarly, the arguments regarding Regulation No 1272/2008 put forward by the applicant in the reply, which seek to demonstrate that the need for harmonisation was established therein, must be rejected, in so far as the specific purpose of that regulation is, in accordance with Article 1(1)(a) of that regulation, to harmonise the criteria for classification of substances and mixtures, and the rules on labelling and packaging for dangerous substances and mixtures. First, Regulation No 1107/2009 does not pursue any objective of transversally harmonising the assessment criteria for chemical substances in order to make them applicable in the context of all the regulatory frameworks involving such substances and, second, the hierarchy of norms does not require Regulation No 1107/2009 to be subject to Regulation No 1272/2008. In that regard, it must be borne in mind that those regulations reflect the political and economic decisions taken by the legislature specific to each of those legislative instruments. 108 In the second place, if the applicant’s argument must be understood as claiming that, by applying the PBT criteria to inorganic substances, contrary to the obligation imposed on it by the scientific and technical knowledge at the time as apparent from other regulatory frameworks, the legislature infringed the principle of proportionality to the point of committing a manifest error of assessment, that argument must be rejected. 109 It is true that Article 4(1) of Regulation No 1107/2009 does indeed require the approval procedure for an active substance to be carried out in the light of current scientific and technical knowledge. 110 However, in accordance with the conclusions reached by the Court in its examination of the first part of the first plea, it is not apparent from the documents submitted by the applicant either that there is a scientific consensus on the issue, or that inorganic substances pose no danger, but only that the approach of using the PBT criteria is not optimal. According to Article 1(3) and Article 1(4) of Regulation No 1107/2009, the purpose of that regulation is to ensure a high level of protection of human and animal health and of the environment, and its provisions are underpinned by the precautionary principle (see, in that regard, paragraph 68 above). 111 As a result, in the absence of an entirely appropriate method for taking into account the potential hazards represented by inorganic substances, the application of the PBT criteria seems, ultimately, to be an appropriate measure for attaining the legitimate objectives pursued by the legislation at issue. It allows the substance concerned to be subject to the CFS regime, which expresses the legislature’s intention progressively to replace that substance with an appropriate solution. In that regard, the documents before the Court show that the copper compounds covered by that measure do appear to be capable of being replaced, contrary to what is claimed by the applicant. It should, in fact, be pointed out that, in the defence, the Commission specifically stated that it was not correct that copper compounds could not be replaced by another fungicide or another bactericide, indicating, by way of illustration and without being contradicted on that point by the applicant in the reply, that, first, there are at least three natural compounds approved at EU level as bactericide and included to that effect in the annex to Implementing Regulation No 540/2011, namely Bacillus subtilis (entry 138), plant oils/clove oil (entry 241) and vinegar (entry 5), second, there are also many other substances that are fungicides, such as fenhexamid, flutianil, and phosphonates and, third, copper compounds could be also replaced by an integrated pest management approach combining alternative compounds and resistant plant varieties. 112 In the light of the foregoing, it must be held that the applicant has not adduced, to the requisite legal standard, the proof necessary to establish a manifest error of assessment on the part of the legislature as a result of applying the PBT criteria to inorganic substances in the context of Regulation No 1107/2009. 113 The second part of the first plea must therefore be rejected. (c) The third part of the first plea: misinterpretation of the precautionary principle and the lack of necessity, as regards the objectives pursued by Regulation No 1107/2009, to apply the PBT criteria to inorganic substances, as regards CFS 114 As a preliminary matter, it must be recalled that it is settled case-law, first, that the principle of proportionality requires that acts of the EU institutions be appropriate for attaining the legitimate objectives pursued by the legislation at issue and do not exceed the limits of what is necessary in order to achieve those objectives, it being understood that, when 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 30 April 2019, Italy v Council (Fishing quota for Mediterranean swordfish), C‑611/17, EU:C:2019:332, paragraph 55 and the case-law cited). 115 Second, as regards judicial review of the implementation of that principle, bearing in mind the wide discretion enjoyed by the EU institutions when they are called upon to regulate situations falling within a complex technical and scientific context that is evolving, as in the present case (see, in that regard, paragraph 64 above), the lawfulness of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate in terms of the objective which the competent institution is seeking to pursue. What must be ascertained, therefore, is not whether the measure adopted by the legislature was the only one or the best one possible but whether it was manifestly inappropriate (see, to that effect, judgment of 30 April 2019, Italy v Council (Fishing quota for Mediterranean swordfish), C‑611/17, EU:C:2019:332, paragraph 56 and the case-law cited). 116 In the third part of its first plea in law, the applicant submits that the contested provisions of Regulation No 1107/2009 infringe the principle of proportionality in so far as the inclusion of copper compounds in the assessment applying the PBT criteria for the purposes of the CFS regime exceeds what is necessary to achieve the objectives of that regulation. 117 In support of its position, first, the applicant notes that the CFS identification mechanism pursues the objective of progressively replacing active substances which have certain properties that the Commission considers to be of concern. Yet, according to the applicant, since copper is present in nature, it cannot be replaced by another substance. However, the substitution at issue relates to copper compounds which, as explained in paragraph 111 above, appear to be capable of being replaced. Furthermore, as the Parliament points out in its statement in intervention, the contested measure is intended to encourage the search for alternatives and thus comes within the scope of the objectives pursued by Regulation No 1107/2009. 118 Second, as regards the fact that, when there is a choice between several appropriate measures, recourse must be had to the least onerous, the applicant submits that there is, in the present case, a possibility of adopting a less restrictive measure. In its observations on the Council’s statement in intervention, the applicant states that an exemption statement for inorganic compounds not to be subjected to a PBT assessment in the working document entitled ‘Evidence needed to identify POP, PBT and vPvB properties for pesticides’ would be sufficient. 119 However, in the context of the examination of the first two parts of the present plea, it was concluded that (i) it was not apparent from the evidence adduced by the applicant that the inorganic substances should be exempted from a hazard assessment, (ii) the applicant had not demonstrated that there was a scientific consensus as regards the inappropriate nature of applying the PBT criteria to inorganic substances and (iii) the measure adopted was appropriate for attaining the legitimate objectives pursued by the legislation at issue. 120 As a result, although those substances continued to be subject to a risk assessment as regards intended uses, it must be concluded that, given that the alternative proposed by the applicant would lead to a total exemption from assessment of the hazards of inorganic substances, without that being justified, the measure that the applicant proposes would not take into account the objectives pursued by Regulation No 1107/2009. 121 Third, in response to the argument put forward by the interveners that the legislature could have opted for a more restrictive approach, the applicant observes that, on the one hand, the alternative envisaged by the Council is not realistic, because it would have led to the prohibition of most plant protection products currently available to farmers and, on the other hand, that does not mean that the choice actually made is proportionate and thus that choice should be assessed on its own merits. 122 In that regard, it should be noted that the system in place allows an alternative to the possible non-renewal of approval of copper compounds. In addition, reassessment according to the most recent scientific data and methods is carried out by reviewing the status of CFS when assessing the renewal of approvals, in accordance with Article 11(2)(c) of Implementing Regulation No 844/2012, read in conjunction with Article 11(3) of that regulation. Lastly, as the applicant itself indicates in the application, scientific developments may lead to a review of Regulation No 1107/2009 so that they may be taken into account. 123 Fourth, with regard to the fact that the disadvantages caused must not be disproportionate to the aims pursued, it should be noted that the applicant considers it illogical to make producers of copper compounds in the European Union subject to the consequences of the CFS regime when it is impossible to substitute copper. In that regard, first of all, it has already been stated in paragraphs 111 and 117 above that the substitution sought by applying the CFS regime to copper compounds is conceivable and that, consequently, the disadvantages caused by the requirement to carry out a comparative assessment are not disproportionate to the aims pursued. Next, the absence of automatic authorisation on the basis of mutual recognition does not preclude Member States from continuing to apply such a mechanism, in accordance with Article 41(2)(b) of Regulation No 1107/2009 (also see paragraph 49 above). Lastly, although shortening the period of renewal may lead to an increase in certain costs as a result of the increase in the frequency of renewals of approval, it nonetheless allows any scientific developments to be raised sooner. 124 Fifth, as regards the applicant’s argument that the precautionary principle cannot justify the legislature’s decision to subject inorganic substances to an assessment applying the PBT criteria, suffice it to note that it is not apparent from the evidence adduced by the applicant that inorganic substances must be exempted from a hazard assessment, but only that, in that context, the application of the PBT criteria is the subject of debate (see, in that regard, paragraphs 82 to 84 and paragraphs 110 and 111 above). As a result, the hazards at issue relate not to hypothetical situations but to potential situations, in accordance with the requirements laid down by the case-law (see, to that effect, judgment of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 184). 125 Furthermore, it must be borne in mind, as the Commission does, that the classification of copper compounds as CFS pursues the objective of progressively finding alternatives. As the Council points out, although the substances in question were not, at the time of the assessment, known to give rise to risks such as to prevent their approval, they nevertheless have properties which could pose a greater risk to human health and the environment than a less dangerous alternative. 126 Sixth, as regards the arguments raised by the applicant regarding the sufficient degree of protection afforded by the regime applicable prior to the adoption of Regulation No 1107/2009, it is sufficient to recall that, in accordance with Article 1(3) thereof, that regulation seeks to ensure a high level of protection of both human and animal health and the environment. As a result, as the Parliament points out in its statement in intervention, the legislature is entirely justified in increasing the degree of protection. The fact that copper compounds are put to other uses in the same environmental compartment or that they are used as fertiliser or manure does not lead to the conclusion that the measure is disproportionate. As was pointed out in paragraph 106 above, there is no legal obligation to harmonise all the regulatory frameworks applicable to copper. Consequently, the proportionality of the measure must be assessed in the context of the situations governed by Regulation No 1107/2009. 127 In the light of the foregoing, it must be concluded that the applicant has not succeeded in demonstrating either that the application of the PBT criteria to inorganic substances exceeded the limits of what was necessary to achieve the objectives pursued by Regulation No 1107/2009, or that that regulation misinterpreted the precautionary principle. 128 It follows that the third part of the first plea in law must be rejected as unfounded and, accordingly, that the first plea in law must be rejected in its entirety. 3. The second plea in law: plea of illegality of Implementing Regulation 2015/408 in relation to the classification of copper compounds as CFS 129 The applicant raises, ad cautelam, a plea of illegality against Implementing Regulation 2015/408, in so far as, although not cited in the contested regulation, it implemented Article 80(7) of Regulation No 1107/2009 by drawing up a list of CFS that included copper compounds. 130 Given that the plea of illegality raised in the context of the first plea in law against Regulation No 1107/2009 aims at removing copper compounds from the scope of application of the PBT criteria, the applicant takes the view that any applications of those criteria to copper compounds must be covered by the effects of a potential annulment of Regulation No 1107/2009. Thus, it submits that, if the Court upholds its first plea in law, the effects of that conclusion must inevitably lead to the removal of the effects of the inclusion of copper compounds on the list of CFS approved by Implementing Regulation 2015/408. 131 Since it has been concluded that the first plea in law should be rejected and since the arguments raised in the context of the present plea are identical, the second plea in law must be rejected. 4. The third plea in law: the contested act infringes the principle of proportionality by renewing the approval of copper compounds as CFS 132 In the alternative, the applicant alleges that the Commission infringed the principle of proportionality by renewing the approval of copper compounds as a CFS instead of subjecting them to the general regime, even though the Commission was aware, at the time of the adoption of the contested regulation, that the guidelines were inappropriate for assessing copper compounds. 133 The applicant submits, in essence, that the Commission exceeded the limits of what was appropriate and necessary, in so far as it should have made copper compounds subject to the general regime on account of (i) the inappropriate nature of the persistence criterion in relation to those compounds, (ii) the fact that the sectoral legislation already takes account of the intrinsic properties of inorganic compounds and that the general approach followed is that those compounds must not be subject to the PBT criteria, and (iii) the fact that subjecting copper compounds to the CFS regime is not necessary in order to achieve the objective pursued by the contested regulation. Moreover, the applicant states that the applicable legislation already foresees a complex notification procedure involving a thorough examination of the safety of a substance and copper has already gone through that process. 134 The third plea in law is based on the premiss that the Commission knew, at the time the contested regulation was adopted, that the application of the PBT criteria to copper compounds was inappropriate. Although it was not demonstrated in the context of the analysis of the plea of illegality raised in the first plea in law that it was inappropriate to apply those criteria, it is nevertheless necessary to examine whether the applicant has proved that factors which arose between the adoption of Regulation No 1107/2009 and the adoption of the contested regulation could alter that assessment. 135 In that regard, first, it may be noted that, although since 2012 Annex XIII to Regulation No 1907/2006 no longer mentions the exclusion of inorganic substances from the scope of the PBT criteria, the guidance published by ECHA in June 2017 expressly states that, in that regulatory framework, the PBT criteria are not applicable to inorganic substances. However, the impact of such a document in the context of determining whether the Commission infringed the principle of proportionality when adopting the contested regulation must be subject to the same reservations as those expressed in paragraph 110 above. 136 Second, it should be noted that the slide show submitted by the applicant as an annex to the reply contains a slide on which it is stated that the ‘PBT criteria are not appropriate for substances with non-hydrophobs properties (ionic substances, perfluorated compounds, UVCB substances, microplastics, etc.)’. Without it being necessary to rule on the meaning of that quotation, which is interpreted differently by the Commission, it is sufficient to note that that reference is found on a slide entitled ‘Emerging issues’ dated 24 May 2019. Consequently, it cannot be concluded that, when the contested regulation was adopted, specific scientific data existed regarding the need not to apply the PBT criteria to inorganic substances. Again, in the absence of any scientific consensus in that regard, the Commission cannot be found to have committed a manifest error and it cannot be criticised for having taken those criteria into account in making copper compounds subject to the CFS regime. Accordingly, it must be held that there is nothing in the file which makes it possible to identify new scientific data or methods which might have led to a different conclusion as regards the status of copper compounds as a CFS. 137 Accordingly, the third plea in law must be rejected as being unfounded. 138 It follows from all the above considerations that the action must be dismissed in its entirety. C. The request to appoint an expert 139 Pursuant to Article 96 of the Rules of Procedure, the applicant asks the Court to name an expert, with the required scientific credentials and impartiality, who could draw up a report or submit an oral statement on the applicability of the PBT criteria to the assessment of copper compounds. 140 However, in the light of the various conclusions drawn from the analysis of the evidence in the file, the request for the appointment of an expert must be rejected. 141 Even if an expert were to conclude that the PBT criteria are inapplicable to inorganic substances, that would not mean that the legislature was under an obligation to take such a conclusion into account in 2009 or that the Commission was under an obligation to take such a conclusion into account in 2018. 142 The identification of such an obligation depends not only on the allegedly inappropriate nature of the PBT criteria with regard to inorganic substances, but also on factors which lead to the conclusion that there was a manifest error of assessment in not taking that inappropriate nature into account. In the present case, the applicant has failed to provide any such evidence. IV. Costs 143 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. 144 Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission. 145 In accordance with Article 138(1) of the Rules of Procedure, the Parliament and the Council must bear their own costs. On those grounds, THE GENERAL COURT (First Chamber) hereby: 1. Dismisses the action; 2. Orders European Union Copper Task Force to bear its own costs and to pay those incurred by the European Commission; 3. Orders the European Parliament and the Council of the European Union to bear their own costs. Kanninen Jaeger Porchia Delivered in open court in Luxembourg on 13 October 2021. E. Coulon M. van der Woude Registrar President * Language of the case: English