Judgment;Summary — ECLI:EU:C:2023:842
Date: 2023-11-09
Language of the case: English
Court formation: Fourth Chamber
Subject matter: Approximation of laws;Research and technological development;REACH
Procedure: Action for annulment;Appeal - unfounded;Appeal - inadmissible
Origin: Germany;France;Netherlands

summary, it must be stated that under Annex XIII to the REACH Regulation the aqueous exposure test for the bioconcentration factor is the preferred method for determining bioaccumulation. However, recourse may also be had to test methods based on food intake if that method causes difficulties. The appellants’ arguments against this interpretation of Annex XIII are unfounded. 2. Legal characterisation of the scientific information on the substances at issue 83. The appellants also present factual arguments in connection with all the grounds of appeal asserting that the specific properties of the substances at issue preclude the use of the bioconcentration factor to determine bioaccumulation. It is necessary in this regard to examine, first, the admissibility of the submission and to clarify the standard of review in the appeal (see a), second, the objections regarding the investigation of the facts (see b) and, lastly, the assessment of the relevant information (see c). (a) Admissibility and standard of review 84. The Commission, and to some extent also ECHA and Germany, take the view that the assessment of the relevant information is not subject to review by the Court on appeal because it requires a fresh assessment of the facts. The appeal is thus inadmissible. 85. They are correct in their view that the evaluation of individual studies cannot be requested on appeal, as the assessment of facts and evidence does not, save where the clear sense of the facts and evidence has been distorted, constitute a question of law which is subject, as such, to review by the Court of Justice in the context of an appeal. (36) 86. Although the appellants attempt to counter this argument by alleging that the General Court distorted facts, in practice they are objecting, first and foremost, to the conclusions which the General Court draws from those facts. 87. This does not mean, however, that the appellants’ submissions regarding the facts are inadmissible. Rather, the Court of Justice has jurisdiction under Article 256 TFEU to review their legal characterisation and the legal conclusions which were drawn therefrom, where the General Court has determined or assessed the facts. (37) Accordingly, the Court has even already ruled that whether the low solubility of a substance must be taken into consideration for the purposes of classifying the aquatic environmental hazards posed by that substance is a question of the legal characterisation of facts which is subject to review on appeal. (38) 88. In the present case, the subsumption of the (essentially undisputed) scientific information on the substances at issue must therefore be reviewed on the basis of the legal test developed above for the determination of bioaccumulation. 89. However, it is primarily the responsibility of ECHA to assess the properties of the substances at issue with a view to whether their bioaccumulation should be determined by reference to the bioconcentration factor or other test methods. Since this is a scientifically and technically highly complex question, ECHA enjoys a broad discretion. The EU judicature may review such measures only to verify whether manifest errors of appraisal have been committed or the limits of discretion have been manifestly exceeded. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the authorities on which alone the legislature has placed that task. (39) 90. In particular, where a party claims that the authority competent in the matter has committed a manifest error, the EU judicature must verify whether that authority has examined, carefully and impartially, all the relevant facts of the individual case on which that assessment was based. (40) Although a broad discretion is also available in the finding of the basic facts, the competent authority must show before the EU judicature that it has taken into consideration all the relevant factors and circumstances. (41) 91. In judicial proceedings, this means, in principle, that the party which is claiming an inadequate investigation of the relevant factors or manifest errors of assessment must first adduce factors justifying the doubts, which are relevant to the decision, regarding the plausibility of the assessment made by the EU authority in question. (42) Only then must that authority rebut those doubts, if necessary. This is not a reversal of the burden of proof, contrary to the appellants’ view, but – on the contrary – a fundamental principle of EU procedural law. Since the EU judicature does not normally investigate of its own motion, the burden of proof nearly always rests with the party which invokes a certain fact. 92. In the present case, the hurdle which the appellants must overcome in order to be successful is even higher as the determination of bioaccumulation is not based on a free, purely scientific assessment of the available information on the properties of the substances in question. Rather, according to the above explanation it is clear from Annex XIII to the REACH Regulation that the determination of bioaccumulation is to be based, as a rule, on an aqueous exposure test for the bioconcentration factor. Recourse may be had exceptionally to other test methods, in particular connected with food intake, only if that method raises particular difficulties. 93. Consequently, the complaint raised by the appellants in the first and second grounds of appeal that, in paragraphs 74 and 156 of the judgment under appeal, the General Court reversed the burden of proof is not convincing. In making the statements in question, the General Court merely made clear that the appellants’ submissions did not give sufficient grounds for doubts as to the plausibility of the assessment by ECHA. (b) Investigation of the facts 94. With regard to the investigation of the facts, by the second limb of the fourth ground of appeal, the appellants object in essence that the General Court stated insufficient reasons for rejecting a complaint in this regard. They had submitted that ECHA had failed to take adequate account of studies published between the two opinions of the Member State Committee in 2015 and 2018. 95. The General Court rejected this complaint in paragraphs 170 and 171 of the judgment under appeal, listing those studies and stating that they had been taken into consideration. 96. Viewed in isolation, this statement of reasons does actually seem very brief. 97. As ECHA explains, however, in paragraph 169 of the judgment under appeal the General Court also refers to the fact that it is apparent from the support documents of the Member State Committee submitted in 2018 that the studies in question were taken into consideration. It would be unreasonable to expect the General Court, as it were, to ‘recapitulate’ the assessment of the studies in those documents in order to demonstrate that the studies were not only mentioned but also substantively taken into consideration. 98. Furthermore, at various points, particularly in paragraphs 185 to 188 and 196 to 200 of the judgment under appeal, the General Court discusses the way in which ECHA and the Member State Committee took some of those studies into consideration. In addition, in paragraphs 73 to 77 of the judgment under appeal, the General Court discusses the examination by the Member State Committee of studies on dietary bioaccumulation. 99. Lastly, the appellants’ argument that the inadequate consideration of those studies can be seen from the fact that ECHA determined the bioaccumulation of the substances at issue is not relevant to this question. It does not concern the examination of the relevant factors, but the conclusions drawn from that information, that is to say, the legal characterisation of the facts, which will be addressed below. 100. Consequently, the General Court rightly rejected the complaint of an inadequate investigation of the facts, and the appellants’ plea in this regard is unfounded. (c) Legal characterisation of the available information 101. As regards the legal characterisation of the available information, the appellants submit, in essence, that because of their hybrid nature (second ground of appeal), the substances at issue have certain properties as a result of which the aqueous exposure test for bioconcentration produces unrealistic results (third ground of appeal). This should have been identified by way of a weight-of-evidence determination of the available studies and led to the use of studies based on food intake (first ground of appeal). 102. In particular, the reliance on the need for a weight-of-evidence determination is based on an already rejected interpretation of Annex XIII to the REACH Regulation, as bioaccumulation is to be assessed principally by reference to bioconcentration. (43) This does not mean, however, that the appellants’ factual submissions cannot demonstrate difficulties precluding the application of that test method. 103. The ‘hybrid’ nature of the substances at issue refers to the fact that the essential characteristic of their structure is an inorganic ring of silicon and oxygen to which organic groups, so-called alkyl groups consisting of carbon and hydrogen, are bound. ECHA, (44) for example, presents the structural formula of D4 as follows: 104. The specific properties of the substances at issue are based on this structure. In particular, their solubility in water is low and the octanol-water partition coefficient is high. This partition coefficient serves as a measure of the relationship between lipophilicity (fat solubility) and hydrophilicity (water solubility) of a substance. The value is greater than one if a substance is more soluble in fat-like solvents such as n-octanol and less than one if it is more soluble in water. (45) For D4, ECHA gives a value of 56 μg/L for water solubility and a value of 6.98 for the partition coefficient. (46) For D5, those values are 17 μg/L and 8.07 (47) and for D6 5.1 μg/L and 8.87. (48) 105. These properties form the basis for the appellants’ submission, which is not disputed by ECHA and the Commission, that the substances at issue are not normally present under natural conditions in water but would either deposit into the water sediment or evaporate into the air. They therefore take the view that ECHA should not have been permitted to base the assessment of bioaccumulation on the bioconcentration factor in the light of aqueous exposure, but should have relied on studies on the intake of the substances at issue through diet. 106. The General Court responds to this submission in paragraph 117 of the judgment under appeal, stating that the appellants had not explained how the substances at issue could be present in certain organisms if they were not present in water. It relies in this regard on the support documents of the Member State Committee which mention, in addition to laboratory studies, studies according to which the substances at issue are present in certain organisms in nature. The General Court’s argument is not convincing, however, as those organisms could have absorbed the substances directly or indirectly from the sediment through diet, as is also argued by the appellants. 107. The appellants’ view is further corroborated by the second paragraph of the introduction to Section C.13 of the Annex to Regulation No 440/2008, according to which the determination of the bioconcentration factor by aqueous exposure for very poorly water soluble substances may not be technically feasible. In addition, for substances with very low water solubility in the aquatic environment, exposure via water may be of limited importance in comparison to the dietary route. According to the eighth paragraph, a partition coefficient above 5 and a water solubility below 10 to 100 μg/l mark the range of substances where testing via aqueous exposure may become increasingly difficult. 108. Nevertheless, the rejection of the appellants’ submission by the General Court proves to be legitimate on other grounds. 109. In particular, it is stated in the sixth paragraph of Section C.13 of the Annex to Regulation No 440/2008 that the aqueous exposure test may also be applied under certain conditions to substances with a partition coefficient above six. The eighth paragraph makes clear that it is not possible to give exact prescriptive guidance on the method to be used based on water solubility and the partition coefficient alone as other factors (analytical techniques, degradation, adsorption, etc.) can have a marked influence on method applicability. 110. Consequently, in the light of the possible difficulties mentioned in paragraph 107, the legislature nevertheless decided that in principle the aqueous exposure test method for determining the bioconcentration factor is preferable. It is only if this method cannot be implemented in practice that the assessment of bioaccumulation through diet takes on crucial importance. 111. According to the opinions of the Member State Committee from 2015 and 2018, reliable studies on the bioconcentration of the substances at issue are available. 112. It is true that by the fourth limb of the third part of the fourth ground of appeal, the appellants complain about the treatment of objections to the growth corrections applied to a CERI study from 2010 in paragraphs 231, 234 and 237 of the judgment under appeal. (49) By those corrections, account is taken of the effects of the growth of the test animals on the results. (50) 113. However, in paragraph 237, the General Court rightly rejected the objection to the CERI study as out of time because it was not raised in the application, as the General Court also explained in paragraphs 200 and 201 of the judgment under appeal. Under Article 84(1) of its Rules of Procedure, no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which come to light in the course of the procedure. 114. Furthermore, this complaint actually no longer concerns the legal characterisation of facts, but the assessment of the abovementioned study and of the objections raised. It is not therefore an admissible subject matter for the appeal. 115. Furthermore, ECHA rightly explains that this (doubly inadmissible) objection relating to growth corrections does not demonstrate a manifest error of assessment, but merely a difference of scientific opinion on the importance of those corrections for the reliability of the results. 116. Lastly, by the fifth limb of the third part of the fourth ground of appeal, the appellants assert that, in paragraph 241 of the judgment under appeal, the General Court wrongly found that there is nothing in the file to indicate the existence of studies refuting the determination of the bioconcentration factor. However, the General Court did not thereby state that there were no studies at all arguing against the use of the bioconcentration factor. The appellants have indisputably cited studies raising methodological objections to the studies relied on by ECHA. However, the contested finding of the General Court merely referred to the fact that the appellants did not cite any studies which concerned the determination of the bioconcentration factor for the same species. 117. In the light of the rules governing the relevant test method for assessing bioaccumulation under Sections 1.1.2 and 1.2.2 of Annex XIII to the REACH Regulation and Section C.13 of the Annex to Regulation No 440/2008 in particular, the determination made by ECHA on the basis of the bioconcentration factor that the substances at issue are bioaccumulative and very bioaccumulative is thus not only free from manifest errors of assessment, but is even more consistent with the legal criteria to be applied than the view taken by the appellants. 118. It was not therefore necessary for ECHA additionally to make comments on dietary bioaccumulation (biomagnification and trophic magnification) in stating reasons for the contested decision. Consequently, the objections raised by the appellants concerning these supplementary reasons are no longer material. 119. The conclusion reached by the General Court is therefore correct, even though its statement of reasons is not entirely convincing in every respect. (d) Interim conclusion 120. The objections to the legal characterisation of the properties of the substances at issue in respect of bioaccumulation are also therefore unfounded. B. First part of the fourth ground of appeal – toxic properties of D5 and D6 121. By the first part of the fourth ground of appeal, the appellants object, lastly, to paragraph 256 and paragraphs 270 to 272 of the judgment under appeal, where the General Court accepted that the identification of toxic properties of D5 and D6 is based solely on the presence of D4, whose toxic properties are established, as an impurity in those substances. 122. This finding is based on the fifth paragraph in the preamble to Annex XIII to the REACH Regulation, according to which the PBT/vPvB properties of relevant constituents of a substance are also to be taken into consideration. 123. While the appellants concede that account must be taken of the presence of D4 as an impurity in the assessment of PBT properties of D5 and D6 as a constituent, they criticise the General Court for accepting, in paragraph 256, the failure to carry out an assessment of the toxic properties of both substances as such. 124. The General Court also gives convincing reasons for its position in paragraph 256, however, stating that an assessment of the toxicity of D5 and D6 as such is not necessary if that property is already apparent from the presence of D4 as an impurity and the data are not complete in other respects. Furthermore, in paragraph 257 of the judgment under appeal, which is not contested, the General Court rightly explains that it would not be compatible with the objective of a high level of protection to forgo the assessment of toxicity in such a situation. 125. In addition, the appellants object to the fact that, in paragraph 271, the General Court rejected as unconvincing their argument that D4 would be released as an impurity in D5 and D6 only in such small quantities that it would not reach a toxic level. On the basis of the statements regarding bioaccumulation, however, the General Court argues convincingly that even D4 released in small quantities could accumulate (in organisms) to such an extent that it has toxic effects. 126. The first part of the fourth ground of appeal is therefore also unfounded and the appeal should be dismissed in its entirety. V. Costs 127. Under Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs. 128. Under Article 138(1) of the Rules of Procedure, which is applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 129. Since the appellants have been unsuccessful and ECHA has applied for costs, the appellants must be ordered to pay those costs. 130. Germany and the Commission, interveners at first instance, should be ordered to bear their own costs pursuant to Article 140(1) of the Rules of Procedure. (51) 131. Furthermore, under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, but it participated in the written or oral part of the proceedings before the Court of Justice, the Court may decide that it is to bear its own costs. Since ACC took part in the proceedings and has been unsuccessful, it should be ordered to bear its own costs. VI. Conclusion 132. I therefore propose that the Court should: (1) Dismiss the appeal; (2) Order Global Silicones Council and the other appellants to bear their own costs and to pay the costs incurred by the European Chemicals Agency (ECHA) in connection with the appeal; (3) Order the Federal Republic of Germany, the European Commission and American Chemistry Council, Inc. (ACC) to bear their own costs. 1 Original language: German. 2 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); the relevant version is as amended by Commission Regulation (EU) 2017/1510 of 30 August 2017 (OJ 2017 L 224, p. 110) (‘the REACH Regulation’). 3 Recital 3 of Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 as regards Annex XIII (OJ 2011 L 69, p. 7). 4 ECHA, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment (Chapter R.11) (28/06/2017), p. 11. 5 ECHA Decision ED/61/2018 of 20 June 2018. 6 Regulation of 30 May 2008 laying down test methods pursuant to the REACH Regulation (OJ 2008 L 142, p. 1). 7 Member State Committee (MSC) Opinion on persistency and bioaccumulation of Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) (https://echa.europa.eu/documents/10162/17233/art77-3c_msc_opinion_on_d4_and_d5_20150422_en.pdf/57c2de97-0420-4cc2-bd32-021006bab026?t= 1430751180565). 8 OECD Test Guideline 305 (2012), Bioaccumulation in Fish: Aqueous and Dietary Exposure, Annex 1. 9 Member State Committee Opinion, cited in footnote 7, pp. 12 to 14. 10 ECHA, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment [Chapter R.11] (28/06/2017), p. 69. 11 The biomagnification factor indicates the concentration of a substance in an organism relative to the concentration in its food (ECHA, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment [Chapter R.11] (28/06/2017), p. 72). 12 Trophic magnification factors describe the accumulation throughout the whole food chain (ECHA, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment [Chapter R.11](28/06/2017), p. 77). 13 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1) (‘the CLP Regulation’). 14 Cited in footnote 3. 15 ECHA, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment (Chapter R.11) (28/06/2017), pp. 66 and 69. 16 In addition to p. 69 of the Guidance, see also p. 71. 17 Commission Regulation (EU) 2017/735 of 14 February 2017 (OJ 2017 L 112, p. 402). It refers to OECD test guideline 305 (2012). 18 First paragraph of the introduction to Section C.13. 19 Eighth paragraph of the introduction to Section C.13. 20 Eighth paragraph of the introduction to Section C.13; see also paragraph 11 of OECD test guideline 305 (2012). 21 Paragraphs 71 and 79 of the application in Case T‑519/18. 22 See below, point 84 et seq. 23 Judgments of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 75); of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207, paragraphs 24 and 25); and of 21 December 2021, PlasticsEurope v ECHA (C‑876/19 P, not published, EU:C:2021:1047, paragraphs 89 and 90). 24 Judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207, paragraph 25). 25 See also, to that effect, contrary to the statements made by the appellants and ACC, the decision of the Board of Appeal of ECHA of 7 December 2016, cited by them (BASF, Case A-013-2014, paragraphs 112 and 113). 26 See also the judgment under appeal in Case C‑558/21 P, delivered by the General Court on 30 June 2021, Global Silicones Council and Others v Commission (T‑226/18, not published, EU:T:2021:403, paragraph 120), which the appellants do not challenge in this regard. 27 Recital 3 of Regulation (EU) No 253/2011 (cited in footnote 3). 28 Recitals 2 and 3 of Regulation (EU) 2017/735 (cited in footnote 17). 29 See above, points 48 and 50. 30 See, to that effect, judgments of 15 October 2009, Enviro Tech (Europe) (C‑425/08, EU:C:2009:635, paragraph 47), and of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 60). 31 Cited in footnote 13. 32 With regard to this structure, see below, point 103. 33 Paragraph 82 of the application in Case T‑519/18. 34 Paragraphs 84 to 87 of the application in Case T‑519/18. 35 With regard to a similar error, see my Opinion in Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2020:735, point 89), and judgment of 6 May 2021, Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2021:367, paragraph 61). 36 Orders of 15 April 2010, Makhteshim-Agan Holding and Others v Commission (C‑517/08 P, not published, EU:C:2010:190, paragraph 62), and of 7 May 2013, Dow AgroSciences and Others v Commission (C‑584/11 P, not published, EU:C:2013:281, paragraph 73). 37 Judgments of 21 September 2006, JCB Service v Commission (C‑167/04 P, EU:C:2006:594, paragraph 106), and of 28 June 2018, Andres (Insolvenz Heitkamp BauHolding) v Commission (C‑203/16 P, EU:C:2018:505, paragraph 77). 38 Judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others (C‑691/15 P, EU:C:2017:882, paragraph 49). 39 Judgments of 15 October 2009, Enviro Tech (Europe) (C‑425/08, EU:C:2009:635, paragraph 47); and of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 60); and, specifically regarding the REACH Regulation, orders of 27 March 2014, Polyelectrolyte Producers Group and Others v Commission (C‑199/13 P, not published, EU:C:2014:205, paragraph 26); of 22 May 2014, Bilbaína de Alquitranes and Others v ECHA (C‑287/13 P, not published, EU:C:2014:599, paragraph 19); and of 4 September 2014, Rütgers Germany and Others v ECHA (C‑290/13 P, not published, EU:C:2014:2174, paragraph 25). 40 Judgments of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14), and of 22 November 2017, Commission v Bilbaína de Alquitranes and Others (C‑691/15 P, EU:C:2017:882, paragraph 35). 41 Judgments of 8 July 2010, Afton Chemical (C‑343/09, EU:C:2010:419, paragraphs 33 and 34); and of 8 December 2020, Hungary v Parliament and Council (C‑620/18, EU:C:2020:1001, paragraphs 114 and 116); and orders of 22 May 2014, Bilbaína de Alquitranes and Others v ECHA (C‑287/13 P, not published, EU:C:2014:599, paragraph 20); and of 4 September 2014, Rütgers Germany and Others v ECHA (C‑290/13 P, not published, EU:C:2014:2174, paragraph 26). 42 See, to that effect, judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719, paragraph 69). See also judgments of 8 December 2011, Chalkor v Commission (C‑386/10 P, EU:C:2011:815, paragraph 65); and of 7 May 2020, BTB Holding Investments and Duferco Participations Holding v Commission (C‑148/19 P, EU:C:2020:354, paragraph 71); and Opinion of Advocate General Szpunar in PlasticsEurope v ECHA (C‑119/21 P, EU:C:2022:655, point 57). 43 See above, point 38 et seq. 44 ECHA, Substance Infocard Octamethylcyclotetrasiloxane, available at https://echa.europa.eu/en/substance-information/-/substanceinfo/100.008.307. 45 Wikipedia, Octanol-water partition coefficient, https://en.wikipedia.org/wiki/Octanol-water_partition_coefficient, consulted on 16 February 2023. 46 ECHA, Brief Profile Octamethylcyclotetrasiloxane, available at https://echa.europa.eu/en/brief-profile/-/briefprofile/100.008.307. 47 ECHA, Brief Profile Decamethylcyclopentasiloxane, available at https://echa.europa.eu/en/brief-profile/-/briefprofile/100.007.969. 48 ECHA, Brief Profile Dodecamethylcyclohexasiloxane, available at https://echa.europa.eu/brief-profile/-/briefprofile/100.007.967. 49 The appellants and the General Court both made clerical errors in this connection. In the second part of the fourth ground of appeal, the appellants allege that in paragraph 200 of the judgment under appeal the General Court confused studies from 2015 with a study from 2018, although in that passage the General Court refers only to studies that were actually mentioned by the appellants in the application and in the reply. In reality, the General Court confused these studies in paragraphs 234, 236 and 237. The confusion is essentially irrelevant, however, as the General Court did address the content of the relevant study. 50 See the fifth paragraph of the Chapter entitled ‘Principle of the test’ in Section C.13, Part I, of the Annex to Regulation No 440/2008. 51 Judgment of 25 October 2017, PPG and SNF v ECHA (C-650/15 P, EU:C:2017:802, paragraph 86).