Judgment;Judgment (extracts);Abstract — ECLI:EU:T:2020:623
Date: 2020-12-16
Language of the case: English
Court formation: Eighth Chamber
Subject matter: Environment;Approximation of laws;Research and technological development;Public health;REACH
Procedure: Action for annulment - unfounded
Origin: Belgium

summary. The applicant claims that in spite of the fact that this study has not been published in full, that evidence was been given a score of 2 in the Klimisch scoring system, that is, ‘reliable with restrictions’, whereas an appropriate scientific assessment would suggest a reliability score of 4, that is to say, ‘insufficient documentation’. 182 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 183 In that connection, it should be recalled, as a preliminary point, that the weight of evidence approach does not preclude ECHA from relying on studies containing certain shortcomings affecting the reliability thereof, where ECHA takes these into consideration in the weighting of the data on which it relies. Furthermore, it is clear that the data on Cyprinus carpio were used only to support the conclusions drawn from the studies conducted on other species of fish, namely Danio rerio and Oryzias latipes, in particular. Consequently, none of the studies conducted on Cyprinus carpio were used as a key study in the weighting of data for the identification of bisphenol A as an endocrine disruptor. 184 As regards, first of all, the Mandich et al. (2007) study, it should be observed that the Support Document finds that that study complies only in part with OECD Test Guideline No 240. In particular, it contains no indication that the endpoints relating to vitellogenin induction or gonad histopathology were analysed in accordance with that validated test guideline. The Support Document finds that study to be reliable without restriction by giving it a reliability score of 1 in the Klimisch scoring system, without differentiating between the various endpoints. Given that that score is, in principle, reserved for studies conducted in full compliance with internationally validated methods, the score given to that study appears to be incorrect. Nevertheless, as noted in paragraph 182 above, ECHA did not find that that study was a key study for the identification of bisphenol A. It served solely as a supporting study in the context of the weight of evidence approach. That study was therefore not decisive for the identification of bisphenol A as a substance of very high concern, but rather simply supported that identification. It follows that, even supposing that ECHA wrongly assessed the reliability of that study, such an error would not call into question the conclusions drawn in particular from key studies as evaluated by ECHA in the Support Document. 185 Next, as regards the Bowmer and Gimeno (2001) study, it should be observed that it is apparent from the Support Document that (i) only one of the two assays used in that study was carried out in compliance with good laboratory practice, as defined by the OECD and (ii) only an extended summary is available. In the light of those considerations, the score of 2 in the Klimisch scoring system (reliable with restrictions) given to that study does not appear to be vitiated by a manifest error of assessment. That said, it is clear that, as is the case for the Mandich et al. (2007) study, the Bowmer and Gimeno (2001) study was used solely to support the identification of bisphenol A. Consequently, even if the score given to that study were to prove to be mistaken, such an error would not call into question the conclusions drawn, in particular, from the key studies. 186 In the light of the foregoing, the arguments put forward with regard to the studies conducted on Cyprinus carpio must be rejected as unfounded and, bearing in mind all of those factors, it must be held that the arguments raised in respect of certain in vivo studies conducted on certain species of fish have failed to demonstrate the existence of a manifest error of assessment vitiating the assessment of those studies which would mean that they could not serve to support the finding of an oestrogenic mode of action of bisphenol A in fish, reached by means of the weight of evidence approach. (6) Conclusion on the first complaint in the second part of the first plea 187 In the light of the foregoing, it is clear that, in exercising its discretion for the identification, in the present case, of bisphenol A as an endocrine disruptor that can have serious effects on the environment, ECHA followed a clear and systematic methodology whilst respecting the principle of excellence for the purposes of appraising the diverse evidence on which it relied. In the context of the weight of evidence approach, ECHA carried out a weighting of in vivo and in vitro data drawn from a multitude of scientific studies whilst taking the reliability of each study into account. That weighting led ECHA to identify an endocrine mode of action in the first place on the basis of certain in vivo studies on certain species of fish and amphibian, whereas other in vivo data – namely, in particular, those on certain species of invertebrate – and in vitro data were used in support of those findings. 188 It is the weight of the evidence drawn from the aforementioned data that permitted ECHA to reach its conclusions with regard to the intrinsic properties of bisphenol A as an endocrine disruptor. In particular, those findings were not drawn from a single individual study, and even less so from a single study used as a supporting study. It must be found that the applicant’s criticisms of certain studies used by ECHA are confined to calling into question the individual relevance or inconclusive nature of those studies, without however demonstrating a material contradiction in the effects reported or a clear inconsistency in the weighting which would invalidate the weight of the evidence. 189 The first complaint in the second part of the first plea must therefore be rejected. (b) The second complaint in the second part of the first plea: manifest error of assessment, in that ECHA failed to establish that there was scientific evidence of bisphenol A having serious effects on the environment on account of its endocrine disrupting properties 190 By the second complaint in the second part of the first plea, the applicant claims that ECHA committed a manifest error of assessment, as it failed to establish that there was scientific evidence of bisphenol A having serious effects on the environment on account of its endocrine disrupting properties. The applicant states that, pursuant to Article 57(f) of Regulation No 1907/2006, only substances which have endocrine disrupting properties ‘for which there is scientific evidence of probable serious effects to … the environment’ can be identified as being of very high concern. 191 The applicant takes the view that the evidence relied upon in the Support Document does not provide a clear hypothesis to demonstrate an endocrine disrupting mode of action in the environment for bisphenol A, but relies solely on the description of individual observations in the context of endocrine disruption, while the scientific arguments are vague and unsubstantiated. The data which supports the existence of low oestrogenic activity for fish and amphibians are not, in the applicant’s opinion, sufficient to identify a substance of very high concern under Article 57(f) of Regulation No 1907/2006. The applicant argues that the evidence is, on the contrary, either extremely poor or highly speculative. The latter criticism applies in particular to the suggested mode of action in fish and amphibians. Nor, it is claimed, is there sufficient evidence obtained, for example by means of in vitro studies, to identify bisphenol A as having an endocrine disrupting mode of action. 192 In support of its argument, the applicant refers to the observations submitted by the Kingdom of Denmark and the United Kingdom at the public consultation. It claims, more specifically, that the United Kingdom expressed its hesitation as to the conclusion that bisphenol A definitely causes its effects via endocrine disruption. 193 Furthermore, the applicant observes that ECHA’s claim that an effect is associated to an endocrine disrupting mode of action does not provide, by itself, sufficient evidence to fulfil the criteria set out in Article 57(f) of Regulation No 1907/2006. The applicant states, generally, that an association between two aspects alone does not, in its view, prove the scientific evidence required. 194 Moreover, the fact that certain serious effects were acknowledged as ‘EATS [estrogen, androgen, thyroid and steroidogenic]-mediated’ is not sufficient scientific proof for an endocrine mode of action of bisphenol A in vivo resulting in serious effects. According to the applicant, the existence of other potential mechanisms should have been examined and excluded. Given that the majority of the in vitro assays on endocrine mechanisms assess molecular initiating events only, other data relating to suspected undesirable effects would have been necessary before it was possible to presuppose that certain effects were ‘EATS-mediated’. Furthermore, the mere assertion that certain effects are known to be ‘EATS-mediated’ is too general, and does not explain which effects are concerned, or how or by whom those effects are known to be ‘EATS-mediated’, or in what way it allowed ECHA to find that there was a biologically plausible link. Consequently, ECHA should have conducted a detailed analysis of the mode of action. 195 The applicant claims that the Support Document does not establish the key biochemical, cellular, and molecular events in the proposed mode of action, or the temporal and dose-response concordance between them, but rather confines itself to postulating their existence in a hypothetical scenario. In doing so, ECHA failed to satisfy the criteria that it identified itself in the Support Document. 196 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 197 In that connection, it is necessary to examine whether ECHA failed to apply the required standard of proof to establish that bisphenol A causes serious effects on the environment on account of its endocrine mode of action. 198 As a preliminary point, it is clear that in paragraph 173 of the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329), the Court held that the probability that a substance may have serious effects on the environment was sufficient to establish a causal link within the meaning of Article 57(f) of Regulation No 1907/2006. In particular, such an approach is in accordance with the precautionary principle, on which the provisions of Regulation No 1907/2006 are based, pursuant to Article 1(3) thereof. 199 Furthermore, the Court stated in paragraph 94 of the judgment of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, under appeal, EU:T:2019:639), that ‘the facts and evidence relied upon in the examination of a substance [had to] serve to establish that it [was] “plausible” that the mode of action of that substance [could] lead to certain serious effects [and that, by] contrast, Article 57(f) of Regulation No 1907/2006 does not require absolute proof of a causal relationship’. 200 In the light of those considerations, the following observations must be made. In the Support Document, ECHA clearly sets out the methodology followed in order to determine whether there is indeed a plausible biological link between the endocrine mode of action of bisphenol A and the serious effects. Following that methodology, ECHA assessed (i) indicators of an endocrine mode of action and (ii) effects of apical endpoints as evidence substantiating the finding that bisphenol A causes serious effects on account of its endocrine mode of action. In that connection, the Support Document regards the in vivo studies in particular as being relevant to determining whether the serious effects are caused by the endocrine mode of action or whether they are solely the consequence of general systemic toxicity. 201 As an example, pages 33 to 35 of the Support Document explain, more specifically, in relation to studies on fish, first, the relevant indicators of an endocrine mode of action, namely, in particular, vitellogenin induction or histological changes and, second, the apical endpoints which, according to the OECD Guidance No 150 for evaluating endocrine disruptors, may be regarded as indicators of an antagonist of oestrogenic hormone receptors, namely, in particular, a reduction in secondary sexual characteristics and the skewing of sex ratios towards females during sexual development. In that regard, the Support Document explains that, in conjunction with the indicators of endocrine activity, the endpoints allow it to be found that there exists an oestrogenic mode of action. 202 It is in the light of those considerations that the Support Document concludes, in respect of Oryzias latipes and Danio rerio, that there is a direct link between the oestrogenic mode of action and the serious effects observed. Those conclusions were drawn from scientific studies analysed in the Support Document, all of which observed vitellogenin induction in Oryzias latipes and Danio rerio. Changes in sex ratios were also observed in Oryzias latipes, inter alia, in the Yokota et al. (2000) key study, and in Danio rerio in the Chen et al. (2015) study. 203 Similarly, in respect of amphibians, the studies analysed in the Support Document, in particular the Iwamuro et al. (2003) and Heimeier et al. (2009) studies, prove there to be a thyroid mode of action which manifested itself by a disruption of the hypothalamic-pituitary-thyroid axis and a delay in development, which led ECHA to conclude that there exists a plausible biological link between the mode of action and serious effects. 204 In the light of the foregoing, it must be held that, contrary to the applicant’s claims, the evidence on which ECHA relied was neither too vague nor too speculative. It was in fact based on the observation of cellular and molecular biochemical events. Those data led ECHA to find that it was biologically plausible that bisphenol A caused its effects on account of an endocrine mode of action. Contrary to what the applicant appears to claim, ECHA did not confine itself to ‘associating a certain effect with a certain mode of action’. 205 Moreover, in the present case, ECHA based its decision primarily on certain key studies concerning certain species of fish as well as certain species of amphibian in order to demonstrate the existence of a plausible biological link. A variety of in vivo and in vitro studies support that conclusion. The plausibility of the existence of a causal link, found by ECHA in the Support Document, therefore cannot be called into question by the mere fact that there remain uncertainties regarding a limited set of data considered in isolation, for example certain elements drawn from the Chen et al. (2015) study, as described above. Even if the studies containing the alleged shortcomings which are relied upon by the applicant had been disregarded by ECHA, the weight of the remaining evidence as a whole would nonetheless have been sufficient to substantiate the conclusion put forward by ECHA as to the plausibility of a causal link between the endocrine mode of action and the serious effects observed. 206 None of the applicant’s arguments call that conclusion into question. 207 First of all, as regards the argument that ECHA confined itself, in its assessment, to assuming, without a detailed analysis, that certain effects of bisphenol A were caused by endocrine mediation, it is admittedly true that the Support Document does presume, in the part describing the methodology used, that some of the effects are endocrine-mediated. Nevertheless, the Support Document substantiates that presumption by referring to scientific publications. Thus, on page 34, the Support Document explains that the skewed sex ratios towards females is the known result of oestrogenic or anti-androgenic exposure during sexual development, whilst citing three reference sources which include publications by the OECD and the WHO International Programme on Chemical Safety. In doing so, ECHA began with a hypothesis that appears to be at least plausible from a scientific perspective and, consequently, meets the standard of proof as to the existence of a biologically plausible causal link between the mode of action and serious effects. 208 Second, as regards the applicant’s argument that the data supporting the existence of weak oestrogenic activity did not suffice to identify an endocrine disruptor, it should be observed, first, that the applicant has failed to define what it means by weak endocrine activity and, consequently, what data it regards as insufficient. Second, the weight of evidence approach allows and requires that all relevant data which supports a hypothesis be taken into account. ECHA was therefore entitled to base its findings also on data demonstrating weak effects only. Third, the degree of the effects observed is not a criterion necessary to establishing a causal link between an endocrine mode of action and its effects. Such a causal link may also be established plausibly on the basis of weak effects. 209 Lastly, as to the applicant’s argument that the United Kingdom expressed its hesitation in relation to the conclusion that bisphenol A undeniably causes its effects through endocrine disruption, it should be noted that that observation on the part of the United Kingdom was in fact made in the light of the data contained in the studies on invertebrates. It follows from page 135 of the Support Document that ECHA did not rely conclusively on the data concerning invertebrates, but confined itself to finding that it was possible that the effects of bisphenol A were caused by endocrine disruption. More specifically, ECHA acknowledges that, in the absence of scientific consensus on the definition of a plausible biological link between the effects and the endocrine mode of action in those species of invertebrate, that evidence can serve only as supplementary evidence, supporting the conclusions drawn in the first place from the studies on fish and amphibians. Accordingly, ECHA cannot be criticised for excluding hesitations such as those expressed by the Kingdom of Denmark and the United Kingdom during the consultation on the draft identification. 210 In the light of all the foregoing, the second complaint in the second part of the first plea in law must be rejected (c) The third complaint in the second part of the first plea: manifest error of assessment in the identification of an equivalent level of concern 211 By the third complaint in the second part of the first plea, the applicant claims that ECHA committed a manifest error of assessment in the identification of the criteria laid down in Article 57(f) of Regulation No 1907/2006 by finding that bisphenol A gave rise to ‘an equivalent level of concern’ to those of other substances set out in Article 57(d) and (e) of Regulation No 1907/2006, namely (i) PBT substances and (ii) vPvB substances. 212 First, the applicant submits that the ready biodegradability of bisphenol A, together with the fact that the potential concentration in the environment does not exceed the safe threshold preclude that substance giving rise to a level of concern equivalent to that of PBT or vPvB substances, on account of the fact that it does not accumulate in the environment. In that connection, the applicant relies on Section 1.1 of Annex XIII to Regulation No 1907/2006, under which a substance does not fulfil the persistence criterion if it is biodegradable. It is argued that the high level of concern associated with PBT and vPvB substances is primarily driven by their accumulation in the environment, due to their persistent and bioaccumulative properties. Although meeting the PBT and vPvB properties is not a precondition to being an endocrine disruptor in the meaning of Article 57(f) of Regulation No 1907/2006, the applicant takes the view that reference should be made to properties that are relevant to the identification of PBT and vPvB substances, namely persistence and bioaccumulation. In support of its argument, the applicant relies on observations made by various Member States, and in particular the Kingdom of the Netherlands and the United Kingdom, on the dossier prepared in accordance with Annex XV, emphasising the ready and immediate biodegradability of bisphenol A. The applicant claims that ECHA responded to those observations by asserting that bisphenol A was readily biodegradable. Nevertheless, ECHA failed to call into question its own conclusions with regard to the equivalent level of concern. The applicant claims furthermore that ECHA failed to demonstrate the existence of an equivalent level of concern by reference to criteria other than persistence or bioaccumulation. 213 In addition, the applicant refers to the determination of a predicted no-effect concentration of bisphenol A in the context of the EU RAR which, it argues, illustrates the possibility of determining a safe level of exposure to bisphenol A. ECHA, however, reached the speculative conclusion that it appeared difficult to find a safe level, but failed to provide any justification for that conclusion, which – according to the applicant – constitutes a manifest error of assessment vitiating the contested decision. 214 Next, inasmuch as ECHA also based its decision on the serious nature of effects as well as the irreversible nature thereof, the applicant maintains that such findings are based on unreliable studies. Moreover, ECHA cannot, in the applicant’s view, rely on the serious nature of effects to justify the level of concern, given that, under Article 57(f) of Regulation No 1907/2006, the serious nature of effects is already taken into account in order to determine whether bisphenol A is a substance for which there is scientific evidence of probable serious effects to the environment. 215 Lastly, in the applicant’s view, the mere fact that the MSC unanimously accepted that there existed such a level of concern was insufficient and could not compensate for a lack of scientific evidence for that assertion. 216 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 217 In that connection, it should be borne in mind from the outset that Article 57(f) of Regulation No 1907/2006 requires, as regards the identification of substances other than those meeting the classification criteria referred to in Article 57(a) to (e) of that regulation, that it be established, on a case-by-case basis, on the basis of scientific evidence, that (i) the substances concerned can have serious effects on human health or the environment, and (ii) those effects give rise to an equivalent level of concern to those of other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, namely CMR, PBT and vPvB substances. Those conditions are cumulative, so that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 26). 218 As regards the second condition laid down in Article 57(f) of the REACH Regulation, there must be scientific evidence that those effects ‘give rise to an equivalent level of concern’ to those of CMR, PBT or vPvB substances. As the Court of Justice notes in paragraph 32 of the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), Article 57(f) of Regulation No 1907/2006 does not lay down any criterion and does not provide any clarification as regards the nature of the concerns that may be taken into consideration for the purposes of identifying a substance other than CMR, PBT or vPvB. Under those circumstances, it is necessary to ascertain whether ECHA committed a manifest error of assessment in its determination of the level of concern. 219 First of all, it should be observed that the Support Document contains, through a weight of evidence approach, a series of considerations which led ECHA to find there to be probable serious effects giving rise to an equivalent level of concern. The Support Document relies, inter alia, on the serious nature of the effects on reproduction and sexual development in fish and amphibians, together with the irreversibility of those effects, which potentially have long-term consequences for the population, even after brief exposure to bisphenol A. Moreover, the Support Document explains that (i) bisphenol A acts on a wide variety of ecologically important species and (ii) exposure to that substance is not confined to certain environments but is instead ubiquitous. Lastly, ECHA relies on the difficulty in determining and quantifying a safe exposure threshold. 220 It is clear that the applicant does not call those findings into question in their entirety. In fact, it confines itself to (i) discussing the possibility of establishing a safe level of exposure to bisphenol A, and (ii) claiming that the ready and immediate biodegradability of bisphenol A – which, moreover, is not disputed by ECHA – precludes the finding of a level of concern equivalent to that of PBT and vPvB substances, inter alia. 221 As regards, first, the possibility of determining a safe level of exposure, it should be noted that, admittedly, a predicted no-effect concentration was determined in the EU RAR. 222 As ECHA explains in its observations on the applicant’s reply to a written question put by the Court, contrary to the work carried out for the purposes of establishing a predicted no-effect concentration, the identification of a substance under Article 57(f) of Regulation No 1907/2006 is not a question of risk analysis, but rather an assessment of the dangers inherent to the intrinsic properties of a substance. Thus the possibility of inferring a safe level in context must be assessed in relation to the dangers that bisphenol A poses to the environment on account of its endocrine mode of action. It is in that context that ECHA took account of the uncertainties highlighted in deriving a safe level. In that connection, the Support Document refers, inter alia, to the difficulties arising from the fact that certain effects can be observed only during certain life stages, time windows or seasons. Furthermore, difficulties were identified on account of the fact that bisphenol A affects a wide variety of organisms though different endocrine modes of action. 223 In the light of those uncertainties – which are, at the very least, plausible – ECHA took a cautious approach to the question of the possibility of determining a safe level of exposure to bisphenol A. That caution is particularly justified in the light of the precautionary principle on which the provisions of Regulation No 1907/2006 are based pursuant to Article 1(1) thereof. That principle, which is a general principle of EU law, means that, where there is uncertainty, appropriate measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see, to that effect, judgments of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43, and of 19 September 2019, GE Healthcare v Commission, T‑783/17, EU:T:2019:624, paragraph 45). Consequently, ECHA cannot be criticised for having justified the level of concern arising from the effects of bisphenol A on account of its endocrine mode of action, in particular, by relying on the uncertainties that it had identified for the determination of a safe level of exposure to bisphenol A. 224 Next, as regards the argument that the ready and immediate biodegradability of bisphenol A precludes the determination of an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006, first, it should be found that that argument is contradictory. On the one hand, the applicant rightly acknowledges that it is not necessary that a substance have PBT or vPvB properties in order to be regarded as an endocrine disruptor for the purposes of Article 57(f) of Regulation No 1907/2006. On the other hand, it takes the view that reference should be made to properties relevant to the identification of PBT and vPvB substances in order to establish an equivalent level of concern. In that context, the applicant has failed, however, to explain which criteria would, in its view, allow the identification of a substance as an endocrine disruptor without that substance being both a PBT and vPvB substance. 225 That interpretation of Article 57(f) of Regulation No 1907//2006, put forward by the applicant, would essentially make that provision a mere duplication of the provisions of Article 57(a) to (e) of that regulation, which would render the provisions of Article 57(f) of that regulation ineffective. In particular, such an interpretation would run counter to the main purpose of Regulation No 1907/2006, set out in Article 1(1) thereof, namely that of ensuring a high level of protection of human health and the environment, in so far as that interpretation would give rise to a situation in which substances of a very high level of concern which do not possess the properties referred to in Article 57(a) and (e) of Regulation No 1907/2006 could not be identified as such. According to the very wording of Article 57(f) of that regulation, that provision covers, in particular, substances ‘which do not fulfil the criteria of [Article 57(d) and (e) of the regulation]’. 226 Second, the applicant has failed to explain the extent to which the ready biodegradability of bisphenol A, in itself, would invalidate ECHA’s conclusions on the level of concern to which bisphenol A gives rise. It is apparent from the Support Document that ECHA found that even brief exposure to bisphenol A may suffice to cause serious, irreversible long-term effects on organisms and populations. Accordingly, the ready and immediate biodegradability of bisphenol A cannot affect the level of concern, as identified by ECHA. 227 Third, it should be borne in mind that ECHA arrived at the determination of a level of concern on the basis of the weight of evidence. Thus the argument that ECHA relied on unreliable studies, which corresponds to the first complaint of the first plea, must also be rejected. The weight of the studies assessed allowed ECHA to conclude, without committing a manifest error of assessment, that the effects caused by bisphenol A on account of its endocrine mode of action are irreversible inasmuch as they are transmitted from one generation to the next, as observed by the various multi-generational studies conducted on species of fish analysed in the Support Document. 228 Lastly, as regards the serious nature of the effects caused by bisphenol A on account of its endocrine mode of action, it should be noted that Article 57(f) of Regulation No 1907/2006 admittedly requires that it be proved that bisphenol A causes serious effects to the environment. Nevertheless, that does not prevent ECHA from considering the serious nature of those effects by comparison to the seriousness of the effects caused by the substances set out in Article 57(a) to (e) of that regulation. In particular, such an approach does not constitute a double counting of evidence, but simply an analysis of that evidence from a different angle. 229 Having regard to that evidence, it is clear that the applicant has failed to demonstrate how ECHA could have committed a manifest error of assessment in establishing an equivalent level of concern. 230 In the light of all the foregoing, the third complaint in the second branch of the first plea in law must be rejected, as must that branch and plea in their entirety. B. The second plea in law: infringement of Article 59(8) of Regulation No 1907/2006, read in conjunction with Article 57(f) of that regulation 231 By the second plea, the applicant claims that ECHA infringed Article 59(8) of Regulation No 1907/2006, read in conjunction with Article 57(f) of that regulation, because it identified bisphenol A as a endocrine disruptor of very high concern on the basis of the criteria laid down in Article 57(f), even though bisphenol A had already been previously identified as a substance of very high concern on account of intrinsic properties, such as those referred to in Article 57(c) of that regulation. In the applicant’s view, each of the risks identified in accordance with the criteria set out in Article 57(a) to (e) of Regulation No 1907/2006 can be addressed correctly by their identification according to the various criteria listed in that article. By contrast, Article 57(f) of Regulation No 1907/2006 is intended to cover only those substances which do not fulfil the criteria laid down in Article 57(a) to (e) of that regulation but for which there is scientific evidence of probable serious effects on human health which give rise to an equivalent level of concern to those of other substances set out in Article 57(a) to (e) of Regulation No 1907/2006. According to the applicant, the legislature included Article 57(f) in Regulation No 1907/2006 for the specific purpose of addressing any substance of concern which has not already been identified as such under Article 57(a) to (e) of that regulation. That being the case, according to the applicant, where a substance has already been identified as a substance of very high concern pursuant to Article 57(a) to (e) of Regulation No 1907/2006, it may not be identified as a substance of very high concern a second time pursuant to Article 57(f) thereof. 232 That is, it is claimed, clear from the wording of Article 57 and from the description of the scope of Article 57(f) of Regulation No 1907/2006 contained in paragraphs 24 and 26 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207). In addition, according to the applicant, if it were necessary to conclude that a substance may be identified both as being a substance which fulfils the criteria set out in Article 57(f) of Regulation No 1907/2006 and as a substance which fulfils the criteria laid down in Article 57(a) to (e) thereof, this would mean that the ‘scientific evidence’ already used to support the probable serious effects on human health of that substance under one of the criteria laid down in Article 57(a) to (e) of Regulation No 1907/2006 would also be used to support the criterion set out in Article 57(f) of that regulation. This is a case of ‘double counting’ of the scientific evidence. This means that the effects of the substance do not give rise to an ‘equivalent’ level of concern, as required by the provisions of Article 57(f), but an ‘identical’ level of concern. Such a requirement was clearly not foreseen by the legislature, according to the applicant. The requirement of an ‘equivalent’ level of concern, as referred to in Article 57(f) of Regulation No 1907/2006, in fact highlights that the ‘basis’ for identification under that provision should be different from the ‘basis’ for identification under one of the criteria referred to in Article 57(a) to (e) of that regulation. 233 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 234 In that connection, it should be observed that, in paragraph 39 of the judgment of 23 January 2019, Deza v ECHA (C‑419/17 P, EU:C:2019:52), which also concerns the amendment of an existing entry in the Candidate List of substances by the addition of a reference to Article 57(f) of Regulation No 1907/2006, the Court of Justice stated that ECHA was empowered to supplement existing entries in the Candidate List of substances with new grounds within the meaning of Article 57 of Regulation No 1907/2006. 235 The applicant’s arguments – which were, moreover, raised identically in support of its action in the case registered under number T‑636/17 – do not call that conclusion into question. As in the judgment of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, under appeal, EU:T:2019:639), those arguments must be rejected as unfounded in their entirety in the present case also. 236 First, it is clear that the applicant’s reasoning cannot, in any event, succeed with regard to endocrine disruptors of very high concern. To the extent that it refers to those substances, Article 57(f) of Regulation No 1907/2006 is the appropriate provision in that regulation for the regulatory classification of those substances. 237 Second, there is no basis for the claim that the legislature included Article 57(f) in Regulation No 1907/2006 for the ‘specific purpose’ of addressing any substance of concern which has not already been identified as such under Article 57(a) to (e) of that regulation. Contrary to the applicant’s claim, it is not clear from Article 57(f) of Regulation No 1907/2006 that that provision is meant to cover only substances which do not meet any of the criteria set out in Article 57(a) to (e) of that regulation. 238 Third, the identification of a substance as fulfilling both the criteria laid down in Article 57(f) of Regulation No 1907/2006 and the criteria set out in Article 57(a) to (e) of the same regulation can, admittedly, result in the different identification procedures being based, in part, on the same scientific evidence so far as concerns the effects on human health. 239 However, contrary to the applicant’s submission, that does not mean that ECHA’s assessment seeks an ‘identical’ level of concern, as opposed to an ‘equivalent’ level of concern. In any event, the fact that an endocrine disruptor gives rise to an ‘identical’ level of concern to that of one of the substances of very high concern referred to in Article 57(a) to (e) of Regulation No 1907/2006 does not preclude the application of Article 57(f) of that regulation. On the contrary, identification as a substance of very high concern is all the more justified if a substance gives rise to an ‘identical’ level of concern to that raised by one of the substances of very high concern referred to in Article 57(a) to (e) of Regulation No 1907/2006. The interpretation of that provision put forward by the applicant is based on a formalism that runs counter to the purpose pursued by Regulation No 1907/2006 which consists, according to Article 1(1) thereof, in ensuring a high level of protection for human health and the environment. 240 Moreover, the applicant misinterprets paragraphs 24 and 26 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207). As ECHA rightly contends, there is a major difference between stating, on the one hand, as the Court of Justice did in paragraph 24 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), that Article 57(f) of Regulation No 1907/2006 ‘covers all other substances which do not fulfil any of the foregoing criteria but “for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed [in Article 57(a) to (e)] and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59”’ of that regulation and, on the other hand, submitting that only substances which do not fulfil any of the criteria listed in Article 57(a) to (e) of Regulation No 1907/2006 may be covered by Article 57(f). 241 The observation made in paragraph 24 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), must be understood as a succinct description of the overall scheme of Article 57 of Regulation No 1907/2006, but which was not made in the light of the question whether it was generally possible, for ECHA, to supplement an existing entry on the Candidate List of substances with dangerous properties under other grounds referred to in Article 57(a) to (f) of the regulation. In other words, the Court of Justice merely noted that substances which did not fulfil any of the criteria listed in Article 57(a) to (e) of Regulation No 1907/2006 can still be covered by Article 57(f) of that regulation, without making the applicability of the latter provision conditional on the non-fulfilment of the criteria listed in Article 57(a) to (e) thereof. On the contrary, in essence, that judgment confirms that the substances referred to in Article 57(f) of Regulation No 1907/2006 do indeed come within the scope of an open category intended to cover the dangerous properties of substances not covered by Article 57(a) to (e) of that regulation. 242 Accordingly, the second plea must be rejected as unfounded. C. The third plea in law: infringement of Article 2(8)(b) of Regulation No 1907/2006 243 In the context of the third plea, the applicant claims that the contested decision infringes Article 2(8)(b) of Regulation No 1907/2006 because bisphenol A is manufactured and used within the territory of the European Union mostly as an ‘intermediate’, whereas, under the clear terms of that provision, isolated intermediates are exempt from Title VII of that regulation in its entirety, and are thus outside the scope both of Articles 57 and 59 of Regulation No 1907/2006 and of the authorisation procedure. The identification of bisphenol A as a substance of very high concern, irrespective of its qualities as an intermediate or non-intermediate substance is therefore, according to the applicant, an infringement of Article 2(8)(b) of Regulation No 1907/2006. 244 The applicant takes the view, first, that the clear wording of Article 2(8)(b) of Regulation No 1907/2006 precludes that provision being interpreted in such a way that deviates from the usual meaning of the words that it contains. Such an interpretation would breach the principle of legal certainty and the principle of inter-institutional balance enshrined in Article 13(2) TEU. It is argued that the legislature made no provision whatsoever for restrictions as to the scope of the similar exception in Article 2(8)(a) of Regulation No 1907/2006, which exempts intermediates from Chapter 1 of Title II ‘with the exception of Articles 8 and 9’ of that regulation. In that regard, the applicant also relies on page 14 of ECHA’s Guidance on Intermediates according to which, first, ‘any use of a substance as an on-site isolated intermediate is not subject to authorisation (i.e. Title VII – Authorisation – does not apply) (Article 2(8)[(b) of Regulation No 1907/2006])’ and, second, that exemption ‘is also valid for intermediates used as monomers for the synthesis of polymers’. 245 Second, the title of Article 57 of Regulation No 1907/2006, ‘Substances to be included in Annex XIV’, shows, in the applicant’s opinion, that the inclusion of a substance in the Candidate List is not an autonomous process, but is only a first step towards the inclusion of that substance in Annex XIV to that regulation. It is claimed that that assessment is supported by the wording of Article 59 of Regulation No 1907/2006, which provides that that article is to apply ‘for the purpose of identifying substances meeting the criteria referred to in Article 57 [of that regulation] and establishing a Candidate List for eventual inclusion in Annex XIV’ to the regulation. In the applicant’s view, the use of the word ‘eventual’ indicates that the inclusion of a substance in the Candidate List will lead to its inclusion in Annex XIV to Regulation No 1907/2006. It argues further that, in paragraph 35 of its judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), the Court of Justice expressly recognised the existence of a link between inclusion on the Candidate List and the scope of the authorisation procedure. Accordingly, given that intermediates are exempt from the authorisation procedure, they should also be excluded from inclusion in the Candidate List. 246 Thirdly, the applicant maintains that a series of provisions shows that, within the context of the system for evaluating substances and authorising uses of those substances, as established by Regulation No 1907/2006, intermediates have a ‘special nature’. In that regard, they are a special category of ‘substances’, which means, moreover, that the provisions of Regulation No 1907/2006 referring to ‘intermediates’ must not be applied or understood as relating to ‘uses’. The ‘special nature’ of intermediates is recognised in recital 41 of Regulation No 1907/2006 and follows implicitly but necessarily from the requirements relating to the registration of those substances, as laid down in Articles 17 to 19 of that regulation. According to the applicant, if the legislature had considered that the exemption of intermediates from Title VII of Regulation No 1907/2006 in its entirety fell short of a high level of protection because intermediates could not be identified in accordance with Article 59 of that regulation, it would have applied a correction to the exemption referred to in Article 2(8)(b) of Regulation No 1907/2006 similar to that constituted by the reference to ‘strictly controlled conditions’ in Article 17(3) and Article 18(4) of that regulation. By not applying such a correction, the legislature clearly intended, in the applicant’s submission, all intermediates to be exempt from Title VII of Regulation in its entirety, with no exceptions or special conditions. 247 Moreover, on-site isolated intermediates that are used in strictly controlled conditions are exempt from the substance evaluation procedure pursuant to Article 49 of Regulation No 1907/2006. Nevertheless, in the applicant’s view, that article provides that a Member State which considers that the use of an intermediate gives rise to a risk equivalent to the level of concern arising from the use of substances which fulfil the criteria under Article 57 of that regulation may request that the registrant provide additional information. The applicant takes the view that such a provision would be meaningless and ineffective if the general risk management provisions laid down under Title VII of Regulation No 1907/2006, and under Article 57 in particular, were to apply to intermediates. 248 Lastly, the applicant submits that the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), is contradictory. On the one hand, the interpretation given by the Court of Justice contradicts its own finding in the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), that Title VII of Regulation No 1907/2006 is a single procedure in which each stage works with the others. On the other hand, the Court of Justice’s interpretation, in paragraph 61 of the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), whereby the exemption set out in Article 2(8)(b) of Regulation No 1907/2006 does not apply to the provisions of Title VII which govern substances in relation to factors other than the uses or categories of use thereof, fails to explain why Article 56 of that regulation deals specifically with the uses of a substance. The applicant claims that the Court of Justice thus failed to explain why the exemption provided for in Article 2(8)(b) is applicable, against its wording, not only to a selected part of Title VII (Chapters 2 and 3 but also to a selected part of Chapter 1 thereof (Articles 57 and 59). 249 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 250 In that connection, it should be pointed out that bisphenol A is used for both intermediate and non-intermediate purposes and that the contested decision makes no distinction between those different types of use. In the context of its third plea, the applicant seeks annulment of the contested decision in the light of those two types of use, whereas its arguments are based in essence solely on the hypothesis that intermediate uses are exempt from Title VII of Regulation No 1907/2006. By contrast, no argument has been put forward in the light of non-intermediate uses of bisphenol A. It follows that, to the extent that it refers to non-intermediate uses of that substance and in the absence of any specific arguments pertaining to that type of use, the fifth plea must be rejected from the outset as ineffective. 251 As regards the intermediate uses of bisphenol A, it should be borne in mind that, under Article 2(8)(b) of Regulation No 1907/2006, ‘on-site isolated intermediates and transported isolated intermediates shall be exempted from Title VII’ of that regulation. 252 In the first place, as regards, in particular, the word ‘intermediate’, it should be observed that, in Regulation No 1907/2006, that word is used as a noun to identify certain substances which, on account of their use, enjoy a derogation, consisting of a reduction in certain obligations laid down by that regulation. In accordance with the definition in Article 3(15) of Regulation No 1907/2006, the word ‘intermediate’ applies to a substance manufactured for and consumed in or used for chemical processing in order to be transformed into another substance, known as ‘synthesis’ (judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraphs 30 and 31). It is apparent from the definition of an intermediate, laid down in Article 3(15) of Regulation No 1907/2006, that the classification of a substance as an intermediate depends on the intended purpose of its manufacture and use (judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraph 34). Notwithstanding the manner in which reference is made to an ‘intermediate’ as though it were a certain type of substance, contrary to the applicant’s submissions, when Regulation No 1907/2006 refers to an ‘intermediate’, it is not referring to a substance of a ‘special nature’ but to a certain type of use of a substance. A certain type of use of substances is therefore covered, inter alia, by Article 17(3) and Article 18(4) of that regulation. 253 Moreover, Article 3(15) of the regulation divides the uses of a substance for ‘intermediate’ purposes into three categories. The first, that of a ‘non-isolated intermediate’, concerns an intermediate that is not intentionally removed from the equipment in which it is synthesised. Regulation No 1907/2006 does not apply to that first category of use of a substance, by virtue of Article 2(1)(c) of that regulation. The second category, ‘on-site isolated intermediate’, applies to any intermediate in respect of which the manufacturing and synthesis take place on the same site. The third category, known as ‘transported isolated intermediate’, concerns any substance used as intermediate which is transported from one site to another. The latter two categories of intermediates are exempted from Title VII of that regulation, by virtue of Article 2(8)(b) of that regulation (judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraph 32). 254 In the present case, it is common ground that since bisphenol A is used primarily as an on-site isolated intermediate or as a transported isolated intermediate, it falls into the second and third categories referred to in paragraph 253 above. 255 In the second place, as regards the question of the exact scope of the exemption provided for in Article 2(8)(b) of Regulation No 1907/2006, it should admittedly be observed that, in paragraph 59 of its judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), the Court of Justice stated in essence that the latter provision, interpreted literally, should lead to the finding that any substance used as an on-site isolated intermediate or as a transported isolated intermediate was, on that ground, automatically exempt from all of the provisions under Title VII of Regulation No 1907/2006. According to the Court of Justice, such a substance would accordingly escape the identification procedure laid down in Article 59 of that regulation, even if, on account of its intrinsic properties, that substance fell under Article 57 of that regulation and should, consequently, be considered to be of very high concern; the authorisation procedure governed by Chapters 2 and 3 of Title VII of that regulation would therefore also not apply to such a substance. 256 However, having regard to the interpretation based on the objective of Regulation No 1907/2006, as referred to in Article 1 and recitals 69 and 70 thereof, the Court of Justice stated, in paragraph 62 of the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), that the exemption laid down in Article 2(8)(b) of Regulation No 1907/2006 concerned only the authorisation procedure laid down in Chapters 2 and 3 of Title VII of that regulation. By contrast, that exemption is inapplicable to the provisions of Title VII of Regulation No 1907/2006, which govern substances in accordance with their intrinsic properties. Article 2(8)(b) of that regulation does not preclude a substance from being capable of being identified as being of very high concern on the basis of the criteria laid down in Article 57 of that regulation, even though it is used merely as an on-site or transported isolated intermediate (judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraph 63). 257 In the present case, in the light of the Court of Justice’s interpretation of Article 2(8)(b) of Regulation No 1907/2006 in the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), ECHA correctly applied Article 59 of that regulation as the basis of the contested decision. 258 Contrary to the applicant’s claims, Article 49 of Regulation No 1907/2006 is neither meaningless nor ineffective in the light of such an interpretation. That article allows Member States, as an exception to the evaluation of substances laid down in Chapter 2 of Title VII of the regulation, to request additional information relating to the risk arising from the use of an on-site intermediate and, where appropriate, to recommend any suitable measure to reduce those risks. Although the risk which triggers those prerogatives of the Member States must be equivalent to the level of concern arising from those of substances which fulfil the criteria laid down in Article 57 of Regulation No 1907/2006, the evaluation of intermediates laid down in Article 49 of that regulation serves a completely different purpose, specifically that of controlling the risks arising from a certain use of a substance as an on-site isolated intermediate. However, the identification of a substance as being of very high concern under Articles 57 and 59 of the regulation does not, on its own, allow a specific risk arising from practical on-site use to be addressed, but instead is carried out with a view eventually to include that substance in Annex XIV to that regulation. Consequently, the objectives of those two provisions are different, with the result that Article 49 of Regulation No 1907/2006 does not preclude a substance which is also used for intermediate purposes from being identified as a substance of very high concern under Articles 57 and 59 of that regulation. 259 In those circumstances, the third plea must be rejected as, in part, ineffective (see paragraph 250 above) and, in part, unfounded (see paragraphs 251 to 258 above). D. The fourth plea in law: infringement of the principle of proportionality 260 In the context of the fourth plea, the applicant claims that the contested decision goes beyond what is appropriate and necessary to attain the objectives pursued by Title VII of Regulation No 1907/2006 and was not the least onerous measure available to ECHA. 261 In the first place, the applicant submits that it follows from the objectives mentioned in recital 69 of Regulation No 1907/2006 that the identification procedure laid down in Articles 57 and 59 of that regulation was designed to play a role in ensuring that careful attention is paid to the substances which pose the greatest risks, namely substances of very high concern. However, due to the fact that intermediate substances are consumed during synthesis (Article 3(15) of Regulation No 1907/2006), those substances pose a much lower risk than other substances. In light of their special nature, the legislator decided that isolated intermediates were not of the highest concern and should thus be exempted from the authorisation procedure altogether. In a case such as the present case, where intermediates represent the majority of the applications of bisphenol A, it is a fortiori disproportionate to include the substance in the Candidate List. In addition, in the applicant’s view, the identification procedure laid down in Articles 57 and 59 of Regulation No 1907/2006 pursues a clear objective, namely that of inclusion in Annex XIV to that regulation. The inclusion of intermediate uses of bisphenol A in the Candidate List will not contribute to the inclusion of bisphenol A in that annex. In those circumstances, the inclusion of bisphenol A in the Candidate List is inappropriate. Lastly, in the applicant’s view, that inclusion was even less appropriate for the purposes of achieving the objectives of Title VII of Regulation No 1907/2006, given that one of the non-intermediate uses of bisphenol A – namely its use in the manufacturing of thermal paper – is already restricted under that regulation. 262 In the second place, ECHA had, in the applicant’s view, a choice of measures and could have acted in a way to avoid confusion and mitigate the effects of lawful use of bisphenol A as an intermediate post inclusion in the Candidate List. In particular, in the applicant’s view, ECHA could have included bisphenol A in the Candidate List as a substance of very high concern, explicitly stating that such identification and inclusion did not apply in so far as bisphenol A meets the definition of an ‘intermediate’. The applicant claims that that measure is legally sound and less onerous than the contested decision as it reconciles the exemption of intermediates in Article 2(8)(b) of Regulation No 1907/2006 with the identification of non-intermediate uses under Article 59 of that regulation. This solution would allow substances used as both intermediate and non-intermediate to be included in the Candidate List, whilst respecting the provisions of Article 2(8)(b) of Regulation No 1907/2006, by explaining that the inclusion in the Candidate List concerns bisphenol A only when it does not meet the definition of an ‘intermediate’, and whilst ensuring better legal certainty with regard to the need to apply for authorisation for intermediate uses under Article 60 of Regulation No 1907/2006. That solution would, according to the applicant, be less restrictive, as undertakings which put bisphenol A on the market solely as an intermediate would not be affected by its inclusion in that list, and it would not prevent the objective of including non-intermediate substances in Annex XIV to Regulation No 1907/2006 being achieved. 263 ECHA, supported by the Federal Republic of Germany, the French Republic and ClientEarth, contests those arguments. 264 As a preliminary point, it should be recalled that the principle of proportionality, which is enshrined in Article 5(4) TEU and which forms part of the general principles of EU law, requires, according to settled case-law, that measures adopted by the institutions do not exceed the limits of what is appropriate and necessary in order to attain the aim pursued; when there is a choice between several appropriate measures recourse must be had to the least onerous (see judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124 and the case-law cited). 265 In the first place, as regards the argument that ‘intermediate substances’ are consumed during synthesis and therefore pose a much lower risk than other substances, it should be observed that the applicant proceeds on a false premiss. As has already been noted in paragraph 260 above, despite the fact that the regulation refers, in some of its provisions, to ‘intermediates’ as though they were a certain type of substance, it refers rather to a certain type of use of certain substances, namely the use of certain substances for intermediate purposes. 266 That being the case, it must be held that, contrary to the applicant’s claim, the mere fact that bisphenol A is used only on rare occasions for non-intermediate purposes does not render the inclusion of that substance on the Candidate List inappropriate. The identification of a substance as a substance meeting the criteria in Article 57 of Regulation No 1907/2006 is based solely on the intrinsic properties of that substance and therefore irrespective of the question of which uses are to be taken into account at the stage of the inclusion in Annex XIV to that regulation, or at the stage of the granting of an authorisation pursuant to Article 60(2) or (4) of that regulation. 267 Moreover, it must be held that the inclusion of bisphenol A on the Candidate List of substances was appropriate to achieve the objective pursued by the provisions of Regulation No 1907/2006 on obtaining information, such as Article 31 of that regulation. 268 Lastly, even supposing that restrictive measures are also appropriate for achieving the objective of Regulation No 1907/2006, that does not mean that restrictions and identification of substances as substances of very high concern are mutually exclusive. As the case-law has already confirmed, the mere fact that a substance appears on the Candidate List of substances does not prevent that substance from being subject to restrictions (see, to that effect, judgment of 25 September 2015, PPG and SNF v ECHA, T‑268/10 RENV, EU:T:2015:698, paragraphs 90 and 91). 269 In the second place, as regards the argument that the principle of proportionality has been breached because there is no reference, in the Candidate List of substances, to the intermediate uses of a substance which is capable of being used both for intermediate and non-intermediate purposes, suffice it to observe that, in its judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), the Court of Justice has already held, in paragraph 79 of that judgment, that the inclusion of a substance in the list of substances for future inclusion in Annex XIV to that regulation with a statement that that listing does not affect the uses exempted under Article 2(8)(b) of that regulation, would be irrelevant for the purposes of applying the principle of proportionality. 270 Furthermore, it should be pointed out that a reference according to which the inclusion of a substance in the Candidate List does not concern intermediate uses – such as that sought by the applicant – could cause confusion as to the question whether information obligations arising from the inclusion in the Candidate List are applicable even in the case of intermediate use. 271 In the light of all of the foregoing, the fourth plea must be rejected as unfounded and, accordingly, the action dismissed in its entirety. IV. Costs 272 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. Since the applicant has been unsuccessful, it must be ordered, in accordance with the form of order sought by ECHA and ClientEarth, to bear its own costs and to pay those incurred by both of the latter. 273 In accordance with Article 138(1) of the Rules of Procedure, the Member States which have intervened in the proceedings are to bear their own costs. Consequently, the Federal Republic of Germany and the French Republic must be ordered to bear their own costs. On those grounds, THE GENERAL COURT (Eighth Chamber) hereby: 1. Dismisses the action; 2. Orders PlasticsEurope to bear its own costs and pay those incurred by the European Chemicals Agency (ECHA) and ClientEarth; 3. Orders the Federal Republic of Germany and the French Republic to bear their own costs. Svenningsen Pynnä Laitenberger Delivered in open court in Luxembourg on 16 December 2020. E. Coulon M. van der Woude Registrar President Table of contents I. Background to the dispute II. Procedure and forms of order sought III. Law A. The first plea: manifest errors of assessment in the application of Article 57(f) of Regulation No 1907/2006 1. The first part of the first plea: manifest error in the assessment of the relevant evidence in the examination referred to in Article 57(f) of Regulation No 1907/2006 (a) The first complaint in the first part of the first plea: manifest error of assessment owing ECHA’s alleged failure to take certain studies into account (1) The alleged failure to take the Clarity-BPA programme into account (2) The studies allegedly disregarded by ECHA (b) The second complaint in the first part of the first plea: the taking into account of allegedly unreliable exploratory studies 2. The second part of the first plea: manifest error of assessment in the identification of bisphenol A as a substance with endocrine disrupting properties for which there is scientific evidence that it may have serious effects on the environment which give rise to an equivalent level of concern to those of substances listed in Article 57(a) to (e) of Regulation No 1907/2006 (a) The first complaint in the second part of the first plea: manifest error of assessment in the assessment of the evidence for the identification of bisphenol A as an endocrine disruptor with serious effects on the environment (1) The assessment of the evidence (2) The in vitro studies (3) The in vivo studies conducted on invertebrates (i) The Oehlmann et al. (2006) study on the snail Marisa cornuarietis (ii) The Duft et al. (2003) and Jobling et al. (2004) studies on the snail Potamopyrgus antipodarum (iii) The Ladewig et al. (2006) study on Lumbriculus variegatus (4) The in vivo studies on amphibians (5) The in vivo studies on fish (i) The Chen et al. (2015) study on zebrafish (Danio rerio) (ii) The Shioda and Wakabayashi (2000) study on Oryzias latipes (iii) The Lahnsteiner et al. (2005) study on brown trout (Salmo trutta fario) (iv) The Bowmer and Gimeno (2001) and Mandich et al. (2007) studies on Cyprinus carpio (6) Conclusion on the first complaint in the second part of the first plea (b) The second complaint in the second part of the first plea: manifest error of assessment, in that ECHA failed to establish that there was scientific evidence of bisphenol A having serious effects on the environment on account of its endocrine disrupting properties (c) The third complaint in the second part of the first plea: manifest error of assessment in the identification of an equivalent level of concern B. The second plea in law: infringement of Article 59(8) of Regulation No 1907/2006, read in conjunction with Article 57(f) of that regulation C. The third plea in law: infringement of Article 2(8)(b) of Regulation No 1907/2006 D. The fourth plea in law: infringement of the principle of proportionality IV. Costs * Language of the case: English. 1 This judgment is published in extract form.