Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE COURT (Fourth Chamber)

9 November 2023 (*)

(Appeal – Establishment of a list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 (REACH Regulation) – Entry of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in that list – Persistent, bioaccumulative and toxic substances (PBT) – Very persistent and very bioaccumulative substances (vPvB) – Bioaccumulation – Bioconcentration factor – Organo-metals)

In Case C‑559/21 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 8 September 2021,

Global Silicones Council, established in Washington, DC (United States),

Dow Silicones UK Ltd, established in Barry (United Kingdom),

Elkem Silicones France SAS, established in Lyon (France),

Evonik Operations GmbH, established in Essen (Germany),

Momentive Performance Materials GmbH, established in Leverkusen (Germany),

Shin-Etsu Silicones Europe BV, established in Almere (Netherlands),

Wacker Chemie AG, established in Munich (Germany),

represented by R. Cana, E. Mullier and Z. Romata, avocats,

appellants,

the other parties to the proceedings being:

European Chemicals Agency (ECHA), represented by W. Broere, A. Hautamäki and M. Heikkilä, acting as Agents,

defendant at first instance,

Federal Republic of Germany, represented initially by J. Möller and D. Klebs, acting as Agents, and subsequently by J. Möller, acting as Agent,

European Commission, represented by L. Haasbeek, R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,

American Chemistry Council Inc. (ACC), established in Washington, represented initially by A. Moroni, avocate, B. Natens, advocaat, and K. Nordlander, advokat, and subsequently by S. De Knop, advocaat, A. Moroni, avocate, and B. Natens, advocaat, and finally by S. De Knop, advocaat, and A. Moroni, avocate,

interveners at first instance,

THE COURT (Fourth Chamber),

composed of C. Lycourgos, President of the Chamber, O. Spineanu-Matei (Rapporteur), J.‑C. Bonichot, S. Rodin, and L.S.Rossi, Judges,

Advocate General: J. Kokott,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after hearing the Opinion of the Advocate General at the sitting on 20 April 2023,

gives the following

Judgment

1        By their appeal, Global Silicones Council, Dow Silicones UK Ltd, Elkem Silicones France SAS, Evonik Operations GmbH, Momentive Performance Materials GmbH, Shin-Etsu Silicones Europe BV et Wacker Chemie AG (together, ‘the appellants’) seek to have set aside the judgment of the General Court of the European Union of 30 June 2021, Global Silicones Council and Others v ECHA (T‑519/18, EU:T:2021:404; ‘the judgment under appeal’), by which the latter dismissed their action seeking annulment, in whole or in part, of the Decision of the European Chemicals Agency (ECHA) of 27 June 2018 including octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexsiloxane (D6) in the Candidate List for eventual inclusion in Annex XIV to 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, corrigendum OJ 2007 L 136, p. 3), as amended by Commission Regulation (EU) 2018/589 of 18 April 2018 (OJ 2018 L 99, p. 7) (‘the REACH Regulation’).

 Legal context

 The REACH Regulation

2        Article 1(1) of the REACH Regulation states:

‘The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.’

3        Article 13(3) of that regulation provides:

‘Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a [European] Commission Regulation or in accordance with other international test methods recognised by the Commission or [ECHA] as being appropriate. The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4).

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.’

4        Under Article 57(d) and (e) of that regulation:

‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

…

(d)      substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

(e)      substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII [to] this Regulation’.

5        Annex XIII to the REACH Regulation (‘Annex XIII’), headed ‘Criteria for the identification of persistent, bio-accumulative and toxic substances, and very persistent and very bioaccumulative substances’, lays down the criteria for the identification of persistent, bio-accumulative and toxic substances (‘PBT substances’), and very persistent and very bioaccumulative substances (‘vPvB substances’), as well as the information that must be considered for the purpose of assessing the P (persistent), B (bioaccumulative) and T (toxic) properties of a substance.

 Regulation (EU) No 253/2011

6        On 15 March 2011, the European Commission adopted Regulation (EU) No 253/2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII (OJ 2011 L 69, p. 7).

7        Recitals 5 and 6 of Regulation No 253/2011 state:

‘(5)      Experience shows that, for the adequate identification of PBT and vPvB substances, all relevant information should be used in an integrated manner and applying a weight-of-evidence approach by comparing the information to the criteria set out in Section 1 of Annex XIII.

(6)      A weight-of-evidence determination is particularly relevant in cases where the application of the criteria set out in Section 1 of Annex XIII to the available information is not straightforward.’

8        Annex XIII, as amended by Regulation No 253/2011, states, in the preamble thereto:

‘This Annex lays down the criteria for the identification of [PBT] substances, and vPvB substances, as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance.

For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.

A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR [(qualitative or quantitative structure-activity relationship)] results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.

The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.

The identification shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant transformation and/or degradation products.

This Annex shall apply to all organic substances, including organo-metals.’

9        Points 1.1.2. And 1.2.2. of Annex XIII, as amended by Regulation No 253/2011, are worded as follows:

1.1.2. Bioaccumulation

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000.

…

1.2.2.            Bioaccumulation

A substance fulfils the “very bioaccumulative” criterion (vB) when the bioconcentration factor in aquatic species is higher than 5000.’

10      Under points 3.2. and 3.2.2. of Annex XIII, as amended by Regulation No 253/2011:

‘3.2.            Assessment Information

The following information shall be considered for the assessment of P, vP [very persistent], B, vB and T properties, using a weight-of-evidence approach:

…

3.2.2.            Assessment of B or vB properties:

(a)      Results from a bioconcentration or bioaccumulation study in aquatic species;

(b)      Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated …

…

(c)      Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.’

 Regulation (EC) No 440/2008

11      On 30 May 2008, the Commission adopted, pursuant to Article 13(3) of the REACH Regulation, Regulation (EC) No 440/2008 (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 2008 L 142, p. 1).

12      Section C.13 of the Annex to Regulation No 440/2008, as amended by Commission Regulation (EU) 2017/735 of 14 February 2017 (OJ 2017 L 112, p. 402), concerns ‘bioaccumulation in fish: aqueous and dietary exposure’.

13      The first paragraph of the introduction to that section C.13 is worded as follows:

‘This test method … is equivalent to [Organization for Economic Co-operation and Development (OECD)] test guideline (TG) 305 (2012). The major goal of this revision of test method is two-fold. Firstly, it is intended to incorporate a dietary bioaccumulation … test suitable for determining the bioaccumulation potential of substances with very low water solubility. …’

 Background to the dispute

14      The background to the dispute is set out in paragraphs 7 to 21 of the judgment under appeal in the following terms:

‘7      […] The first applicant, Global Silicones Council, is a non-stock corporation, established in the United States, representing companies which manufacture and sell silicone products throughout the world. The other applicants … are companies which manufacture, sell and supply the chemical substances octamethylcyclotetrasiloxane (“D4”), decamethylcyclopentasiloxane (“D5”) and dodecamethylcyclohexsiloxane (“D6”) on their own or in a mixture.

8      On 14 October 2014, the Executive Director of [ECHA] requested the ECHA Member State Committee (“the MSC”) to prepare an opinion on the persistence and bioaccumulation of D4 and D5 against the criteria in Annex XIII.

9      On 17 April 2015, the United Kingdom of Great Britain and Northern Ireland submitted to ECHA a dossier based on Annex XV to [the REACH Regulation] (“Annex XV”) proposing a restriction of the use of D4 and D5 in cosmetic products that were washed off in normal conditions of use. The restriction proposal was based on the purported PBT and vPvB properties of D4 and on the purported vP [and] vB properties of D5.

10      On 22 April 2015, the MSC adopted an opinion according to which both D4 and D5 met the criteria set out in Annex XIII regarding the identification of vP and vB [properties].

11      On 10 March 2016, the ECHA Committee for Risk Assessment (“the RAC”) adopted an opinion on the basis of an examination of the United Kingdom’s restriction proposal and of the MSC’s opinion. The RAC, referring to the MSC’s opinion of 22 April 2015, stated that it had not reassessed the vP and vB properties of D4 and D5, but that it had examined the T properties of those substances. The RAC concluded that D4 fulfilled the identification criteria for PBT and vPvB substances set out in Annex XIII and that D5 fulfilled the identification criteria for vPvB substances, but that the latter, on the basis of the available evidence, did not meet the criteria set out in Annex XIII for toxicity.

12      A restriction concerning D4 and D5 was adopted by the Commission on 10 January 2018 (Regulation (EU) 2018/35 amending Annex XVII to Regulation No 1907/2006 [of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)] as regards [octamethylcyclotetrasiloxane (“D4”) and decamethylcyclopentasiloxane (“D5”)] (OJ 2018 L 6, p. 45)). By application received at the Court Registry on 2 April 2018, the majority of the applicants in the present case brought an action for annulment of that restriction. ECHA has intervened in support of the Commission in the case.

13      On 1 March 2017, the competent authority of the Federal Republic of Germany submitted dossiers under Article 59(3) of Regulation No 1907/2006 in accordance with Annex XV, proposing that D4 and D5 be identified as substances of very high concern on account of their [P, B, T, vP and vB] properties. On 21 December 2017, the Commission, under Article 59(2) of that regulation, requested ECHA to prepare a dossier in accordance with Annex XV for the identification of D6 as a substance of very high concern. ECHA concluded in that dossier that D6 met the [P, B, T, vP and vB] criteria.

14      On 8 March 2018, ECHA published the three dossiers prepared in accordance with Annex XV relating to D4, D5 and D6, respectively … . On the same day, ECHA invited all interested parties to submit their comments on those dossiers, in accordance with Article 59(4) of [the REACH Regulation]. ECHA received comments including, on 23 April 2018, those of the applicants.

15      Subsequently, the German competent authority and ECHA produced three documents …, dated 12 June 2018, containing those authorities’ responses to all the comments received by ECHA in the course of the public consultation.

16      Having received comments concerning the identification of the three substances at issue, ECHA, in accordance with Article 59(7) of Regulation No 1907/2006, referred the dossiers to the MSC. In accordance with the MSC’s working procedures for the identification of substances of very high concern, the MSC was provided with an Annex XV dossier, a draft MSC agreement and a draft support document for each of the three substances.

17      At its 60th meeting, held from 12 to 14 June 2018, the MSC reached unanimous agreements on the identification of D4, D5 and D6 as substances of very high concern, on the ground that those substances met the criteria for identification as PBT and vPvB substances under Article 57(d) and (e) of [the REACH Regulation]. The grounds for those agreements are set out in the respective support documents.

18      The support documents for D4 and D5 refer several times, including in the summaries concerning the persistence and bioaccumulation of the two substances, to the MSC’s opinion of 22 April 2015 on D4 and D5 and, concerning the toxicity of D4, to the RAC’s opinion of 10 March 2016. The data are supplemented in the support documents for D4 and D5 by references to new studies published after those opinions. The support document for D4 concludes that D4 has [P, B, T, vP and vB] properties in accordance with Annex XIII. The support document for D5 does not evaluate data on the toxicity of that substance for human health or the environment. That document concludes that D5 is a vPvB substance and that, when it contains D4 in a concentration greater than or equal to 0.1% (weight by weight), it is also PBT.

19      The support document for D6 presents, inter alia, assessments on the degradation and distribution of that substance and refers to data provided in the support documents for D4 and D5. The support document for D6 does not assess the environmental and human-health toxicity of D6. It concludes that D6 is a vPvB substance and states that it also meets the criteria for PBT substances when it contains D4 in a concentration greater than or equal to 0.1% (weight by weight). In addition, given that D4 and D5 were identified as impurities in D6, it concluded, with reference to the MSC’s opinion of 22 April 2015 and the RAC’s opinion of 10 March 2016, that D6 also fulfils the criteria for vPvB substances when it contains D4 or D5 in a concentration greater than or equal to 0.1% (weight by weight).

20      On 27 June 2018, pursuant to Article 59(8) of [the REACH Regulation], ECHA adopted Decision ED/61/2018 regarding the inclusion of D4, D5 and D6 in the Candidate List for eventual inclusion in Annex XIV to Regulation No 1907/2006, as referred to in Article 59(1) of that regulation (“the Candidate List”), on the ground that they had been identified as PBT and vPvB substances within the meaning of Article 57(d) and (e) of Regulation No 1907/2006 [(“the decision at issue”)], published the same day on ECHA’s website.

21      On the same day, the Candidate List published on ECHA’s website in accordance with Article 59(10) of that regulation was updated to include entries for D4, D5 and D6. The remarks on the respective Candidate List entries provide that D5 fulfils the criteria laid down in Article 57(d) of [the REACH Regulation] for a PBT substance when it contains a quantity of D4 greater than or equal to 0.1% (weight by weight). For D6, the remark states that that substance fulfils the criteria laid down in Article 57(d) of [the REACH Regulation] for a PBT substance when it contains a quantity of D4 greater than or equal to 0.1% (weight by weight). As regards D6, the remark also states that, in addition to its intrinsic properties, that substance also meets the criteria set out in Article 57(e) of [the REACH Regulation] for a vPvB substance when it contains a quantity of D4 or D 5 greater than or equal to 0.1% (weight by weight).’

 The procedure before the General Court and the judgment under appeal

15      By application lodged at the Registry of the General Court on 3 September 2018, the appellants brought an action for annulment in whole or in part of the decision at issue.

16      By decision of 10 January 2019, the President of the Fifth Chamber of the General Court granted the Federal Republic of Germany leave to intervene in support of the form of order sought by ECHA.

17      By order of 1 February 2019, the President of the Fifth Chamber of the General Court granted the Commission’s application for leave to intervene in support of the form of order sought by ECHA.

18      By order of 8 April 2019, the President of the Fifth Chamber of the General Court granted the American Chemistry Council Inc. (ACC) leave to intervene in support of the forms of order sought by the appellants, applicants at first instance.

19      In support of their action, the appellants relied on two pleas in law.

20      The first plea alleged manifest error of assessment on the part of ECHA in its assessment of the B properties of D4, D5 and D6 and in its assessment of the T properties of D5 and D6, that it exceeded its powers and infringed Article 59 of the REACH Regulation. That plea was divided into eight parts alleging (i) manifest error of assessment on the part of ECHA, in that it relied on the opinions of the MSC and the RAC without conducting its own assessment of the information available to it, thereby ‘importing’ the errors vitiating those opinions; (ii) manifest error of assessment on the part of ECHA, in that it concluded that D4, D5 and D6 met the PBT and vPvB criteria set out in Annex XIII even though P and B properties were not established for the same compartment; (iii) manifest error on the part of ECHA in that it failed to take into consideration the hybrid nature of D4, D5 and D6; (iv) manifest error of assessment on the part of ECHA, in that it reached conclusions on the bioaccumulation of D4 and D5 which the evidence relied upon was incapable of supporting; (v) manifest error of assessment on the part of ECHA in that it failed to assess the new evidence on bioaccumulation (B and vB properties) for D4 and D5 available to ECHA after the opinions of the MSC and the RAC had been issued; (vi) manifest error of assessment on the part of ECHA, in that it failed to take into account all the relevant information in concluding on the bioaccumulation of D6 and, (vii) and (viii) manifest error of assessment on the part of ECHA, in that it failed to take into consideration the information on the toxicity of D5 and D6 on their own, and identified D5 and D6 as PBT substances based on the presence of D4 as an impurity, and without taking account of the specific limits relating to the quantity of D4 agreed upon by the MSC.

21      The second plea alleged breach of the principle of proportionality.

22      By the judgment under appeal, the General Court rejected each of the pleas in law relied upon and, accordingly, dismissed the action in its entirety.

 Forms of order sought by the parties before the Court of Justice

23      By their appeal, the appellants, supported by the ACC, claim that the Court should:

–        set aside the judgment under appeal;

–        annul the decision at issue;

–        alternatively, refer the case back to the General Court to rule on the application for annulment;

–        order ECHA to pay the costs of these proceedings, including the costs of the proceedings before the General Court, including those of the interveners.

24      ECHA, supported by the Federal Republic of Germany and the Commission, contends that the Court should:

–        dismiss the appeal; and

–        order the appellants to pay the costs.

 The appeal

25      In support of their appeal, the appellants rely on four grounds of appeal:

–      first, misinterpretation of Annex XIII and of Regulation No 253/2011, in that the General Court ruled, in the context of the assessment of the B/vB properties of a substance, that bioconcentration factor (‘BCF’) data has ‘certain priority’ or ‘greater weight’ than other data;

–      second, misinterpretation of Annex XIII, in that the General Court ruled that ECHA did not manifestly err by not taking into account the relevance of the hybrid nature of D4, D5 and D6, as well as distortion of the pleas and evidence and infringement of the right to be heard;

–      third, misinterpretation of Annex XIII, in that the General Court ruled that ECHA did not manifestly err by not taking into account the data obtained in relevant conditions, as well as distortion of the pleas and evidence and infringement of the right to be heard;

–      fourth, material inaccuracy in the General Court’s findings and distortion of evidence.

 The first ground of appeal

 Arguments of the parties

26      The appellants, supported by the ACC, submit that the ‘weight-of-evidence determination’, within the meaning of the REACH Regulation, means that, when examining whether a substance meets the B and vB criteria, the BCF data, laid down in point (a) of Section 3.2.2 of Annex XIII, should not be taken into account in isolation, but that it is appropriate also to consider different categories of information, such as the biomagnification factor (‘BMF’) or the trophic magnification factor (‘TMF’), which are expressly referred to in point (c) of that section. All data relating to the substances examined should therefore be assessed together in the light of the criteria set out in Section 1 of that annex and no specific data, such as BCF data, should take precedence over the other relevant and available data, such as BMF or TMF data, as is apparent in particular from a textual interpretation of Section 3.2.2 of Annex XIII, recitals 5 and 6 of Regulation No 253/2011 and ECHA’s ‘Guidance on Information Requirements and Chemical Safety Assessment’.

27      In the first place, the appellants submit that the General Court erred in law by holding, in paragraph 71 of the judgment under appeal, that the EU legislature chose to give priority to the results of reliable studies on the BCF the weight of evidence of which was greater than that of other available data, and by finding, in paragraph 68 of that judgment, that the priority given to the BCF data is corroborated by Sections 1.1.2 and 1.2.2 of Annex XIII, which set criteria for identifying B or vB substances in relation to their BCF in aquatic species and, in paragraphs 69 and 70 of that judgment, that the weight-of-evidence determination does not apply if the BCF data can be applied ‘directly’ to the criteria laid down in Section 1 of that annex.

28      Accepting that a certain category of data be granted ‘priority’ or ‘greater weight’ (paragraph 71 of the judgment under appeal) or a certain ‘importance’ (paragraph 72 of that judgment) compared to other data goes against the very notion of ‘weight-of-evidence’, as defined in Annex XIII, which requires that all available results be assembled together ‘regardless of their individual conclusions’ and renders that concept ineffective.

29      In the appellants’ view, by stating that the data referred to in Section 3.2.2 of Annex XIII gain in importance when the BCF data cannot be applied directly to the available information, the General Court actually held that it is appropriate to attach no particular relevance or effect to the data referred to in points (b) and (c) of that section where results, within the meaning of point (a) of that section, are available.

30      However, that assessment made by the General Court is supported, in the appellants’ submission, neither by the second paragraph of the preamble to Annex XIII nor by recitals 5 and 6 of Regulation No 253/2011, which do not state that a weight-of-evidence determination is relevant where the direct application of B/vB criteria to BCF data is not possible, but instead state that that determination is particularly relevant where the direct application of B/vB criteria to all the available information is not possible. Such an interpretation is also in accord with the third paragraph of the preamble to that annex, which stresses the need to consider all the available information, regardless of the individual conclusions. The judgment under appeal wrongly gives priority to BCF data precisely on account of the possibility of applying those conclusions numerically to the criteria laid down in section 1 of that annex. However, a weight-of-evidence approach should have been used in the present case in the assessment of the B and vB properties of the substances concerned, irrespective of whether the General Court considered that BCF data could be applied directly/numerically to the criteria in Section 1 of Annex XIII.

31      According to the appellants, Annex XIII requires that both BCF and BMF and/or TMF data be considered, without there being any order of priority. Where results from those data are available but contradictory, as in the present case, and where the properties of the substance indicate that one category of data is not relevant, as is also the case for the BCF, it is consistent with the inherent consistency of that annex that a weight-of-evidence determination examining data other than the BCF data which are of equal importance, should in principle have particular relevance.

32      However, the judgment under appeal suggests, in the appellants’ submission, that the results on the BCF data are sufficient in themselves to establish a presumption of ‘concern’ for B/vB properties, which can only be rebutted if other data ‘refute’ (paragraph 73 of the judgment under appeal), ‘invalidate’ (paragraph 74 of that judgment), ‘contradict’ (paragraphs 83 and 130 of that judgment) or ‘dispel’ (paragraphs 129 and 155 of that judgment) those results.

33      In the second place, the appellants submit that, in paragraph 74 of the judgment under appeal, the General Court reversed the burden of proof by holding that the absence of biomagnification of a substance in one food chain does not prove the absence of biomagnification of that substance in other food chains. In doing so, the General Court disregarded the fact that the REACH Regulation does not require that evidence be adduced as to the absence of biomagnification in all possible food chains, but nevertheless requires ECHA to demonstrate that a substance meets the criteria set in order to be identified as a B or vB substance, which has not been demonstrated in the present case..

34      In the third place, the General Court also committed an error of assessment, in paragraphs 76 and 77 of the judgment under appeal, by failing to exercise its power to review the process leading to the adoption of the decision at issue, since (i) it wrongly rejected the results of a laboratory BMF study in which the fish were exposed via their diet and which demonstrated a very low BMF, by reference, without any valid basis, to the MSC’s explanations according to which those results could not be compared to what happens in the actual environment where the fish are exposed through both diet and the aquatic environment; and (ii) it failed to criticise the approach taken by ECHA, which classified data on other substances with a low BMF and high BCF as being relevant without carrying out a comparison between the properties of those substances and those of the substances concerned in the present case.

35      According to ECHA, supported by the Federal Republic of Germany, the weight-of-evidence approach under Annex XIII does not preclude the possibility of giving different weight to different data, with the result that the complaint as to the misinterpretation of that annex and of Regulation No 253/2011 should be rejected as unfounded. As regards the other errors allegedly committed by the General Court, ECHA submits that the appellants’ line of argument is, principally, inadmissible, since the appellants seek thereby to obtain a fresh assessment of the facts. That line of argument is, in any event, unfounded.

36      The Federal Republic of Germany adds that not only should a ‘certain priority’ be given to the BCF, but it could have been found, moreover, that the BCF was decisive, in so far as, in the present case, the concentration of D4, D5 and D6 in fish was 5 000 times higher than in the surrounding water.

37      As regards paragraph 71 of the judgment under appeal in particular, the Commission adds that, inasmuch as the appellants dispute the General Court's assessment of the weight of the BCF, their line of argument seeks, in reality, to obtain a fresh assessment of the facts and should, therefore, be rejected as inadmissible. By contrast, in so far as the appellants’ line of argument relates to the error of assessment which the General Court allegedly committed by giving priority to the results of reliable studies on the BCF, that is ineffective. Even if the General Court had erred in law by giving fundamental priority to those results, quod non, its assessment cannot be called into question since, in the present case, the MSC considered, without committing a manifest error of assessment, that the BCF values had greater weight than the other data to which the appellants refer.

 Findings of the Court

38      In the context of the first ground of appeal, the appellants, supported by the ACC, essentially submit that paragraphs 68 to 72, 74, 76 and 77 of the judgment under appeal are vitiated by errors of law consisting in (i) a misinterpretation of Annex XIII in so far as concerns the priority given by the General Court to BCF data, (ii) a reversal of the burden of proof, and (iii) disregard on the part of the General Court of the limits of its power of review.

39      As regards, in the first place, the priority given by the General Court, in paragraphs 68 to 72 of the judgment under appeal, to the results of reliable studies on the BCF of a substance in aquatic species, it follows from the scheme of Annex XIII, as amended by Regulation No 253/2011, that the weight-of-evidence determination assumes that all the available information which may have an impact on the identification of a PBT or vPvB substance is taken into consideration together, irrespective of the respective conclusions thereof, with appropriate importance being given to the quality and consistency of the data.

40      Under the second paragraph of the preamble to that annex, for the identification of PBT substances and vPvB substances, in a weight-of-evidence determination, a comparison is to be made of all relevant and available information listed in Section 3.2 of that annex – namely, in particular, the relevant and available BCF, BMF and TMF data – with the criteria set out in Section 1 thereof.

41      According to Section 1 of Annex XIII on the criteria for the identification of PBT and vPvB substances, bioaccumulation is defined by reference to the BCF in aquatic species. Thus, a substance is ‘bioaccumulative’ (B) where the BCF of that substance is higher than 2 000, and ‘very bioaccumulative’ (vB) where the BCF thereof is higher than 5 000.

42      It is clear from the second paragraph of the preamble to Annex XIII that the weight-of-evidence determination is to be applied in particular where the criteria in Section 1 thereof – including the BCF – cannot be applied directly to the available information. That is also clear from recital 6 of Regulation No 253/2011, under which a weight-of-evidence determination is particularly relevant in cases where the application of the criteria under that Section 1 to the available information is not straightforward.

43      As the Advocate General observes in points 44 to 50 of her Opinion, it is apparent from a reading of that preamble and that recital 6 that the weight-of-evidence determination must first of all clarify, by taking into account all the available information set out in Section 3.2 of Annex XIII, whether the available studies have determined the BCF relevantly and reliably. If that is the case, the relevant and reliable BCF data take priority in the scheme of Annex XIII inasmuch as bioaccumulation is directly related to that data. That interpretation cannot be called into question by the integration effected by Regulation 2017/735, amending Regulation No 440/2008, of the dietary exposure test method – that is, the biomagnification or trophic amplification test method – which is adapted to substances with very low water solubility, as a method used for determining bioaccumulation in fish, as in exposure via the aquatic environment.

44      Consequently, the General Court was able to find, without erring in law, in paragraphs 71 to 72 of the judgment under appeal, that the EU legislature chose to give priority to the results of reliable studies on the BCF of a substance in aquatic species. As the General Court rightly stated in paragraphs 68 to 71 of that judgment, that priority does not affect the application of the weight-of-evidence determination. It is in that context that the General Court held that the MSC had not committed a manifest error of assessment by finding that the BCF data had greater weight than that of other data to which the appellants referred, namely the BMF and TMF data. Consequently, the appellants’ line of argument that it is apparent from the judgment under appeal that no particular relevance or effect should be attached to the data referred to in Section 3.2.2 (b) and (c) of Annex XIII where results on bioconcentration are available, is evidence of a misreading of that judgment and must, accordingly, be rejected as unfounded.

45      Moreover, in so far as the first ground of appeal, which alleges misinterpretation of Annex XIII, concerns the General Court’s assessment of the specific way in which the weight-of-evidence determination was applied in the present case and the weight given to BCF data in the weighing up of the various items of evidence, that ground of appeal must be rejected, in the absence of any claim of distortion, as inadmissible.

46      In so far as concerns, in the second place, the alleged reversal of the burden of proof by the General Court in paragraph 74 of the judgment under appeal, in that it implicitly considered that the appellants had to adduce evidence of the absence of biomagnification in all food chains, it should be observed that the General Court held, in that paragraph, that the ‘the data resulting from the field studies indicating that there was no trophic magnification in certain food webs [had been] taken into consideration’ by the MSC, which found that ‘those data did not invalidate the other evidence supporting the conclusion on bioaccumulation’. It is in that context that the General Court stated, first, that the absence of bioaccumulation by means of biomagnification did not preclude the possibility of bioaccumulation by means of bioconcentration and, second, that the absence of biomagnification of a substance in a food chain did not prove that that substance does not biomagnify in other food chains.

47      A reversal of the burden of proof would have meant that, in the absence of proof concerning the bioaccumulation of a substance, the appellants were required to demonstrate the absence of bioaccumulation, which was not the case in this instance. By contrast, as the Advocate General observes in point 91 of her Opinion, 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, with it being for the latter, if necessary, to rebut that plausibility; this does not constitute a reversal of the burden of proof.

48      In so far as concerns, in the third place, the allegedly insufficient review carried out by the General Court, in paragraphs 76 and 77 of the judgment under appeal, of certain findings made by the MSC and ECHA, it should be recalled at the outset, as the General Court noted in paragraphs 51 and 52 of the judgment under appeal, that, in an area of evolving and complex technology such as that in the present case, the competent EU authorities have a broad discretion, whereas review by the Courts of the European Union has to be limited to examining whether the exercise of that discretion is vitiated by a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion (see, to that effect, judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60, and of 9 March 2023, PlasticsEurope v ECHA, C‑119/21 P, EU:C:2023:180, paragraph 46).

49      It is not apparent from the appellants’ arguments that the General Court misinterpreted the limits of its power of review. However, the appellants appear to be calling into question, without relying on any distortion, the assessment, carried out by the General Court, of the results of the dietary test to which they referred and of the reference made by the MSC to other substances in order to illustrate that it was not unusual for a substance with a BMF of less than 1 resulting from a dietary test to have a BCF meeting the criteria for identifying B or vB properties.

50      In doing so, the appellants seek, in reality, to obtain a fresh assessment of the evidence produced before the General Court. However, under Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union, an appeal is limited to points of law. The General Court has exclusive jurisdiction to find and appraise the relevant facts and assess the evidence. It follows that, in the context of an appeal, the Court of Justice has no jurisdiction to establish the facts or, in principle, to examine the evidence which the General Court accepted in support of those facts (judgment of 9 March 2023, PlasticsEurope v ECHA, C‑119/21 P, EU:C:2023:180, paragraph 84).

51      The first ground of appeal must therefore be rejected as being in part unfounded and in part inadmissible.

 The second ground of appeal

 Arguments of the parties

52      The appellants, supported by the ACC, submit that Annex XIII applies to organic substances, including organo-metals, but not to inorganic substances. A substance is organic if it contains only carbon, hydrogen, oxygen, and potentially nitrogen. D4, D5 and D6 have unique properties on account of their hybrid nature, which translates into different properties in terms of solubility and partitioning between environmental media, which influence their distribution and fate in the environment. According to the appellants, D4, D5 and D6 biodilute, their concentration decreases with increases in trophic level, and they metabolise once taken up by organisms via the dietary route, which means that they will not build up in the food chain.

53      It follows, according to the appellants, that the BCF data are not directly relevant for the purposes of assessing the B and vB properties of those substances, since bioconcentration studies are conducted under artificial conditions in which not only are the substances prevented from partitioning to air and sediments, but also the concentration of the substances in water is kept constant. The results of those studies therefore do not reflect the behaviour of the substances in the environment under ‘relevant conditions’, within the meaning of the fourth paragraph of the preamble to Annex XIII. By contrast, the BMF and TMF are relevant parameters.

54      In that context, the appellants submit, in the first place, that the General Court failed to address the arguments that they put forward at first instance with regard to the consequences arising from the hybrid nature of the substances concerned for the purposes of applying the criteria set out in Annex XIII. By contrast, the General Court confined itself to ruling, in paragraphs 140, 141 and 150 of the judgment under appeal, that a substance with an organic/inorganic hybrid structure is not excluded from the scope of that annex.

55      In the second place, it is argued that in paragraph 151 of the judgment under appeal, the General Court (i) reversed the burden of proof by ruling that the appellants had not put forward any evidence capable of demonstrating that ECHA failed to take into account the specific properties of a substance, and (ii) disregarded the evidence that the appellants had put forward in order to establish that failure. In the appellants’ view, ECHA failed to demonstrate that it had taken the hybrid nature of the substances concerned into consideration when assessing them under that annex, and the General Court erred in law by ruling that that failure did not constitute a manifest error of assessment.

56      In paragraph 156 of the judgment under appeal, the General Court again reversed the burden of proof, it is argued, by ruling that the appellants had failed to demonstrate that ECHA had committed a manifest error of assessment in so far as concerns the taking into account, by the latter, of dietary exposure via the food chain. The appellants claim that they submitted detailed observations demonstrating that ECHA had failed to take into account the specific properties of D4, D5 and D6 arising from their hybrid nature, justifying the use of the BMF data in order to assess the B and vB properties thereof, with the result that ECHA was required to demonstrate that it had indeed taken those specific properties into consideration when adopting the decision at issue.

57      In the third place, the appellants challenge the General Court’s findings set out in paragraphs 117, 126, 152, 153 and 155 of the judgment under appeal, in that these are based, in essence, on a distortion of the facts.

58      Thus, first, as regards paragraphs 117 and 152 of the judgment under appeal, the General Court wrongly stated therein that, according to the appellants, D4, D5 and D6 were not found in water or in the environment. The appellants dispute having made such absolute assertions in that regard and refer, by way of illustration, to their reply and their answers to the questions put by the General Court, in order to establish that they alleged and demonstrated that the hybrid properties of D4, D5 and D6 influence their behaviour and their fate in the environment such as to call for a different finding to that made the General Court as to the B/vB properties of those substances.

59      Second, it is argued that, in so far as concerns the metabolism of D4, D5 and D6, the General Court wrongly referred, in paragraph 126 of the judgment under appeal, to the absence of sufficiently concrete and tangible evidence concerning the appellants’ claim that D4, D5 and D6 are metabolised by organisms. However, the appellants submit that they presented, in the application at first instance, scientific proof to that effect, such as, in particular, the Domoradzki et al. 2017 and Gobas et al. 2015 studies, which both address metabolism in fish.

60      It is argued that, in paragraph 153 of the judgment under appeal, the General Court, next, wrongly held that the appellants’ claims as to the metabolism of the substances in benthic, pelagic and terrestrial species had not been substantiated. According to the appellants, while the General Court admittedly took into account, in paragraph 128 of that judgment, the Selck et al. 2018 study on which the appellants relied, it nevertheless disregarded the main conclusion of that study, which is that the substances at issue are metabolised even in sediment-dwelling organisms at such levels that bioaccumulation cannot occur.

61      It is further submitted that, in paragraph 155 of the judgment under appeal, the General Court, lastly, made incorrect findings. The appellants thus claim not to have alleged that the substances at issue are fully metabolised, and take the view that the conclusion reached by the General Court, in paragraph 127 of that judgment, that ‘even if such metabolism did occur, it would not be sufficiently strong to exclude bioaccumulation by bioconcentration’ is unfounded. Similarly, the General Court’s assertion, also in paragraph 155, that ECHA’s finding concerning the vB properties of D4, D5 and D6 was supported by the data on biomagnification drawn from dietary studies, is invalidated by the Gobas 2018 study.

62      ECHA, supported by the Commission, submits that the second ground of appeal should be rejected as inadmissible or, in any event, as unfounded.

63      In their reply, the appellants add, with regard to the alleged infringement of the right to be heard, that the mere fact that their arguments were distorted and not addressed by the General Court constitutes such an infringement.

 Findings of the Court

64      The second ground of appeal concerns the assessment, carried out by the General Court, of the consequences arising from the intrinsic properties of D4, D5 and D6 as a result of their hybrid nature, in the light of the assessment criteria laid down in Annex XIII.

65      In the first place, the appellants criticise paragraphs 140, 141 and 150 of the judgment under appeal in which, it is argued, the General Court distorted their arguments. The appellants submit that they argued not that D4, D5 and D6 should be excluded from the scope of the REACH Regulation on account of their hybrid nature, but rather that the intrinsic properties of those substances are such as to influence the application of the criteria laid down in Annex XIII for the purposes of identifying them as PBT or vPvB substances.

66      In that connection, it should be observed, as the Advocate General also notes in points 77 to 81 of her Opinion, that, while it is apparent from the application at first instance that the appellants criticised ‘how the criteria in Annex XIII to [the REACH Regulation] should be applied’, the General Court’s finding concerning the application of that annex to the substances at issue does not affect the appellants’ interests.

67      In fact, in the scheme of that judgment, that finding is a step prior to the examination of the intrinsic properties of D4, D5 and D6 arising from their hybrid nature, and of their effect on the assessment of the P, B, T, vP or vB properties of those substances. Thus, as ECHA contends, without being contradicted by the appellants, the General Court did not confine itself to finding that D4, D5 and D6 fall within the scope of the REACH Regulation, but it also examined the appellants’ objections based on the effect of the hybrid nature of those substances in the light of the application of Annex XIII. The criticism of paragraphs 140, 141 and 150 of the judgment under appeal must therefore be rejected as ineffective.

68      As regards, in the second place, the complaint alleging reversal of the burden of proof by the General Court, in that the latter stated, in paragraphs 151 and 156 of the judgment under appeal, that the appellants had failed to put forward any evidence capable of demonstrating that ECHA had failed to take into consideration the information on the hybrid nature of D4, D5 and D6, and that it had committed a manifest error of assessment in so far as concerns dietary exposure via the food chain, that must be rejected as unfounded. As has been mentioned in paragraph 47 of the present judgment, the General Court simply stated, rightly, that it is for the appellants to adduce before it factors justifying the plausibility of the doubts or the manifest errors on which they rely.

69      In so far as concerns, in the third place, the consequences arising from the specific properties of D4, D5 and D6, it should be observed, as ECHA also claims and as is apparent from paragraph 151 of the judgment under appeal, that the General Court did not rule that such properties cannot be classified as relevant information, within the meaning of Section 3.2 of Annex XIII, which may be relied upon in the context of the weight-of-evidence determination. However, it did conclude that, in the present case, the factors adduced by the appellants were not capable of demonstrating that ECHA had failed to take those properties into consideration or that such an omission had a bearing on the identification of D4, D5 and D6 as PBT or vPvB substances.

70      The appellants dispute that conclusion of the General Court by claiming that the findings set out in paragraphs 117, 126, 152, 153 and 155 of the judgment under appeal rest on a distortion of their arguments and of the evidence submitted in support thereof.

71      As regards, first, the distortion of their arguments, the appellants submit, on the one hand, that they did not make such absolute assertions that ‘D4, D5 and D6 are not found in water’ and, on the other hand, that they did not claim that those substances were wholly metabolised in certain organisms.

72      First, it should be noted that the appellants do not dispute that their written pleadings could be read by the General as meaning that D4, D5 and D6 were not found in water. Any distortion should be clear from the judgment under appeal, which is not the case in this instance. Furthermore, in paragraph 118 of the judgment under appeal, the General Court referred to the hypothesis in which the substances at issue were not released ‘from sediment into water above the level of solubility’ and observed that low water solubility does not mean that ‘there is no bioconcentration in aquatic species’.

73      Second, it should be observed that the appellants have failed to substantiate the allegation of distortion in so far as concerns the metabolism of D4, D5 and D6 in certain organisms. Moreover, paragraph 155 of the judgment under appeal, which is disputed by the appellants, is part of the General Court’s reasoning set out in paragraphs 153 to 155 of that judgment. Thus, after having correctly set out the appellants’ arguments in paragraph 153 of that judgment, the General Court found that (i) the metabolism of the substances at issue in fish and in sediment-dwelling organisms had been examined in the context of the second part of the first plea in law and (ii) the argument on metabolism of those substances in other organisms had not been substantiated. It was only in the alternative that the General Court examined, in paragraph 155 of that judgment, the argument that ‘the substances at issue [are] fully metabolised in certain organisms’ in order to conclude that ‘that would not call into question ECHA’s conclusion concerning the vB properties of D4, D5 and D6 based on high BCF values and supported by multiple sources of data on biomagnification drawn from dietary studies’.

74      As regards, next, the alleged distortion of the evidence, in that the General Court failed to take into account studies submitted by the appellants relating, inter alia, to the metabolism of D4, D5 and D6 in fish, it should be observed that that complaint is based on a selective reading of the judgment under appeal since, as is apparent from paragraphs 170 to 172 of that judgment, the Domoradzki et al. (2017) and Gobas et al. (2015) studies, to which the appellants refer in the appeal, had been dealt with in the support documents for D4 and D5 and taken into account in the decision-making process.

75      It is clear from the foregoing that the appellants’ complaints alleging distortion of the arguments and evidence seek, in reality, to obtain from the Court an interpretation thereof other than that set out by the General Court in the judgment under appeal and must, therefore, be rejected as inadmissible.

76      As regards, in the fourth place, the infringement of the right to be heard, it should be recalled that that right requires that the person concerned be placed in a position in which he can effectively make known his views as regards the information on which the competent authority intends to base its decision. However, the appellants’ criticisms are directed against the rejection, by the General Court, of complaints made against the decision at issue. Furthermore, observance of the right to be heard in the context of judicial proceedings does not mean that the court has to incorporate in full in its decision all the submissions put forward by each party, but rather that, after listening to the submissions of the parties and assessing the evidence, it must decide whether or not to grant the relief sought in the application and give reasons for its decision (judgment of 11 January 2007, Technische Glaswerke Ilmenau v Commission, C‑404/04 P, EU:C:2007:6, paragraph 125).

77      It follows that the second ground of appeal must be rejected as in part ineffective, in part unfounded and in part inadmissible.

 The third ground of appeal

 Arguments of the parties

78      By their third ground of appeal, the appellants, supported by the ACC, challenge, in particular, paragraphs 88 to 90 and 116 to 119 of the judgment under appeal, and submit that the General Court erred in applying an overly formalistic distinction between risk assessment and hazard assessment.

79      They thus submit that it follows from the fourth paragraph of the preamble to Annex XIII that the information used for the purposes of assessment of the PBT/vPvB properties ‘is to be based on data obtained under relevant conditions’. They also cite paragraph 114 of the decision of the Board of Appeal of ECHA of 7 December 2016 (Case A-013-2014), which states that although the ‘relevant conditions’ do not necessarily equate to ‘real life conditions’, the fourth paragraph of the preamble to Annex XIII nevertheless requires that ECHA take into account the intrinsic properties of the substance at issue in order to allow for a correct estimation of the substance’s behaviour in the environment.

80      However, in paragraph 88 of the judgment under appeal, the General Court, it is submitted, wrongly rejected the appellants’ arguments relating to the fate and behaviour of the substances in the environment on the ground that they were irrelevant, in that they related to the risk assessment rather than the hazard assessment. That distinction between risk assessment and hazard assessment cannot lead to the exclusion of considerations of the actually applicable environmental conditions, that is to say, of ‘relevant conditions’, within the meaning of the fourth paragraph of the preamble to Annex XIII, on the ground that this is an assessment of exposure to those substances which ECHA is not required to examine in the context of a hazard assessment. According to the appellants, assessing whether a substance meets the P, B, T, vP or vB criteria under ‘relevant conditions’ necessarily entails looking at how that substance behaves in the environment, taking into account the intrinsic properties of that substance.

81      The General Court therefore misinterpreted the fourth paragraph of [the preamble to] Annex XIII and, by rejecting those arguments, infringed the appellants’ right to be heard.

82      ECHA contends that the third ground of appeal should be rejected as unfounded. It submits, in that regard, that the interpretation put forward by the appellants of the fourth paragraph of the preamble to Annex XIII is substantiated neither by the decision of the Board of Appeal of ECHA of 7 December 2016 (Case A-013-2014) nor by OECD Guideline 305, which lays down the standardised test method for measuring the bioconcentration of a substance.

83      In the Commission’s submission, the third ground of appeal is a fresh ground, in so far as, at first instance, the appellants argued that the ‘relevant conditions’ require that each property (P, B and T) be assessed in the same environmental sphere. Reliance on that ground at the appeal stage is therefore inadmissible. In any event, the Commission takes the view that that ground of appeal is unfounded, in that it is based on a misunderstanding of the identification of the hazards of a chemical.

 Findings of the Court

84      As preliminary point, it should be observed that, by their third ground of appeal, the appellants criticise the distinction made by the General Court between risk assessment and hazard assessment as well as the consequences arising therefrom as to the identification of a substance as being of very high concern, within the meaning of Articles 57 and 59 of the REACH Regulation. Consequently, that ground of appeal cannot be regarded as new at the appeal stage.

85      More specifically, the appellants challenge paragraphs 88 to 90 and 116 to 119 of the judgment under appeal which relate, in essence, to the concept of ‘relevant conditions’ within the meaning of the fourth paragraph of the preamble to Annex XIII, which states that ‘the information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions’.

86      In that connection, it should be noted that the Court of Justice has on numerous occasions already upheld, in the context of the REACH Regulation, the distinction between risk assessment and hazard assessment. Thus it has ruled that the criteria set out in Annex XIII are based on the assessment of the hazards presented by PBT and vPvB substances, referred to in Article 57(d) and (e) of that regulation, and do not require, in respect of the substances concerned, a risk assessment to be carried out analogous to that required, in the context of the evaluation procedure, under Section 6 of Annex I to that regulation, or, in the context of the authorisation procedure, under Article 64(4) thereof, or, as regards the restriction procedure, under Article 70 of the REACH Regulation (see, to that effect, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraphs 24 and 25).

87      It follows that the General Court rightly held, in paragraph 89 of the judgment under appeal, on the basis of the distinction between risk assessment and hazard assessment, that how a substance behaves in the environment forms part of the risk assessment. In the context of Annex XIII, the concept of ‘relevant conditions’ therefore relates not to how the substance concerned behaves in the environment, but rather to whether the test methods are suitable for identifying the hazardous intrinsic properties of that substance.

88      Consequently, as the Advocate General observes in point 68 of her Opinion, the judgment under appeal is not therefore vitiated by an error in law because the General Court declined to understand the concept of ‘relevant conditions’ to the effect that the test methods for assessing bioaccumulation must be consistent with the actual presence of the substances in question in the environment.

89      In so far as concerns the distortion of the pleas and evidence on which the appellants also rely in support of the third ground of appeal, it should be noted that they rely thereon formally, without substantiating it by means of elements which allow the identification of the plea or item of evidence that the General Court allegedly distorted.

90      As to the alleged infringement of the right to be heard, the appellants’ arguments cannot succeed for the same reasons as those set out in paragraph 76 of the present judgment.

91      The third ground of appeal must therefore be dismissed as being unfounded.

 The fourth ground of appeal

92      The fourth ground of appeal is divided into three parts relating to (i) the taking into consideration by the General Court of information on the toxicity of D5 and D6 on the basis of the presence of D4 as an impurity; (ii) the evidence on bioaccumulation of D4 and D5 subsequent to the opinions of the MSC and RAC; and (iii) the taking into consideration of all relevant information in the context of the assessment of the bioaccumulation of D6.

 The first part

–       Arguments of the parties

93      The appellants, supported by the ACC, submit that ECHA identified D5 and D6 as PBT substances, on the ground that D5 and D6 contain D4 as an impurity and that D4 has P, B and T properties. In the light of the available data on those substances, ECHA failed, however, to take into account the fact that neither D5 nor D6 itself has the T property.

94      The appellants do not dispute that D4 is present as an impurity in D5 and D6. They claim, however, that where these are tested directly, neither D5 nor D6 is toxic to the environment. While the fifth paragraph of the preamble to Annex XIII provides that the information on impurities/constituents is to be taken into account, the identification of a substance is to be based on the information on the substance itself and, ‘also’, on the relevant constituents of that substance.

95      It is argued, in the first place, that the General Court erred, in paragraph 256 of the judgment under appeal, by finding that ‘the word “also” does not indicate that ECHA should have assessed the toxicity of D5 and D6 as such’.

96      In the second place, in paragraph 270 of that judgment, the General Court held that the explanations provided by ECHA in relation to the toxicity of D5 and D6 were ‘plausible’ whereas, in paragraph 271 of that judgment, it stated that the appellants’ argument that D4, in so far as it is released into the environment as an impurity of D5 and D6, would never reach a toxic level because of its low water solubility and its high octanol-water partitioning coefficient, ‘is unconvincing’. According to the appellants, the General Court failed to substantiate that assertion and thereby deprived them of their right to be heard.

97      In the third place, in paragraph 272 of that judgment, the General Court distorted the appellants’ arguments, it is argued, by holding that D4 is not released into the environment. In reality, in the application at first instance, and in their reply before the General Court, the appellants stated that, inasmuch as D4 is released in the form of impurities from D5 and D6, the release of D4 does not reach toxic levels on account of its intrinsic properties.

98      Thus, in the appellants’ submission, the General Court carried out an assessment of the toxicity of D5 and D6 without providing any basis whatever for that assessment with a view to supporting it, in breach of the limits of its power of review.

99      ECHA contends that the fourth ground of appeal is inadmissible in that, by way of their line of argument, the appellants seek, in reality, to obtain from the Court a fresh assessment of the facts and evidence already examined by the General Court.

100    In ECHA’s submission, the first part of that ground of appeal should be rejected as ineffective, in so far as the toxicity of D5 and D6 has no effect on the assessment of the vP and vB properties of those substances and does not invalidate the conclusion that D5 and D6 are classified as substances of very high concern in the light of their vP and vB properties.

101    In any event, the appellants’ arguments in the context of that first part are also unfounded.

102    According to the Commission, it is apparent from the fifth paragraph of the preamble to Annex XIII that the identification of a PBT or vPvB substance may also be based on the presence of P, B, T, vP or vB properties in any of the constituents of that substance, including the impurities or the transformation and/or degradation products of that substance.

–       Findings of the Court

103    In the first place, the appellants challenge the interpretation, by the General Court, of the fifth paragraph of the preamble to Annex XIII, according to which the identification of a PBT or vPvB substance also takes into account the P, B, T, vP or vB properties of the relevant constituents of a substance  and the transformation and/or degradation products thereof.

104    In that connection, it should be observed that, in paragraph 256 of the judgment under appeal, which is contested by the appellants, the General Court held that the adverb ‘also’ does not indicate that ECHA should have assessed the toxicity of D5 and D6 as such when it knew that the data were not complete in that regard or that the toxicity of those two substances was already apparent from other available data, in particular the data relating to D4 present as an impurity in D5 and D6. The appellants have failed to establish that that statement is incorrect. Furthermore, paragraph 256 of the judgment under appeal is in conformity with the objective pursued by the REACH Regulation, as is apparent from Article 1 thereof and as recalled by the General Court in paragraph 257 of that judgment, which is to ensure a high level of protection of human health and the environment.

105    In the second place, the appellants submit that the General Court failed to substantiate its assessment of the evidential value of the explanations furnished by ECHA and the appellants, and confined itself to describing them, in paragraphs 270 and 271 of that judgment, respectively, as ‘plausible’ and, in essence, as being unconvincing. While the appellants formally rely on distortion of the evidence, it is apparent from their arguments that they actually rely on an infringement, by the General Court, of its obligation to state reasons. Paragraphs 270 and 271 of the judgment under appeal must be read in the context of paragraphs 267 to 271 of that judgment, which set out the reasons why ECHA did not take into account the toxicity data resulting from the tests carried out with D5 and D6, in themselves. Moreover, for the same reasons as those set out in paragraph 76 of the present judgment, the General Court’s findings set out in paragraphs 270 and 271 of the judgment under appeal show no infringement of the right to be heard.

106    In the third place, in so far as concerns the appellants’ criticism relating to paragraph 272 of the judgment under appeal, it should be found that the General Court neither disregarded nor distorted the evidence produced by the appellants, but described it as not substantial. The appellants challenge that paragraph by stating that they had not argued that D4 was not released into the environment, but rather that the release of that substance would not reach toxic levels on account of its intrinsic properties. It should be noted that that argument put forward by the appellants was examined and rejected by the General Court in paragraph 271 of that judgment, paragraph 272 thereof being set out for the sake of completeness, which is demonstrated by the use of the word ‘furthermore’. The complaint directed against paragraph 272 of the judgment under appeal must therefore be rejected as ineffective.

107    The first part of the fourth ground of appeal must therefore be rejected as being in part unfounded and in part inadmissible.

 The second part

–       Arguments of the parties

108    The appellants, supported by the ACC, submit that ECHA failed to examine new information on D4 and D5 which admittedly became available after the opinion of the MSC was issued, but before the decision at issue was adopted. However, the General Court, in the first place, wrongly found, in paragraphs 170, 171, 175 and 177 of the judgment under appeal, that the studies had been ‘dealt with’ by ECHA and examined ‘critically’ without stating the reasons which led it to make that assertion.

109    In the second place, in paragraphs 178 and 180 of the judgment under appeal, the General Court committed an error of assessment, on the one hand, by considering that the appellants had failed to cite any specific examples of data for which it would have been impossible for them to know the manner in which they had been assessed and, on the other hand, by holding that the appellants had given a number of examples which, according to them, demonstrated that ECHA had not carefully examined new information.

110    In the third place, in so far as concerns the growth corrections applied to the BCF values, the General Court, it is argued, wrongly found, in paragraph 200 of the judgment under appeal, that the Gobas et al. 2015 study had been used in order to determine whether a growth correction had been made. According to the appellants, that study does not indicate that a growth correction was applied to the BMF values. By contrast, the Gobas 2018 study highlighted issues with the growth correction applied by ECHA.

111    In the fourth place, in paragraph 208 of the judgment under appeal, the General Court erred in its assessment of the facts and the arguments put forward by the appellants. The appellants submit that ECHA is not required to assess, in respect of each study, whether the samples were potentially contaminated. However, where an issue of contamination is identified, as was the case in this instance, ECHA should take this into account in the weight-of-evidence determination.

112    ECHA submits that, by the second part of the fourth ground of appeal, the appellants seek, in reality, to obtain a fresh assessment of the facts of the case and, accordingly, their arguments should be rejected as inadmissible. Those arguments are also unfounded.

–       Findings of the Court

113    By its first complaint in support of the second part of its fourth ground of appeal, the appellants essentially criticise the General Court for having found, without sufficient explanation, that ECHA had duly taken into account new studies on bioaccumulation of D4 and D5, which came after the opinions of the MSC and the RAC.

114    That complaint thus alleges, in essence, infringement on the part of the General Court of its obligation to state reasons. In that connection, it should be recalled that, according to settled case-law, the obligation on the General Court to state reasons for its decisions, under Article 36 and the first paragraph of Article 53 of the Statute of the Court of Justice of the European Union, does not require it to provide an account that follows exhaustively and one by one all the arguments put forward by the parties to the dispute. The reasoning may therefore be implicit, on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 2 September 2021, Ja zum Nürburgring v Commission, C‑647/19 P, EU:C:2021:666, paragraph 36 and the case-law cited).

115    In the light of that case-law, it must be found that paragraphs 170, 171, 175 and 177 of the judgment under appeal, in which the General Court found, in essence, that various scientific studies had been examined critically during the decision-making process, are not vitiated by any failure to state reasons, since those paragraphs should be read in the context of the judgment under appeal. As the Advocate General also observes in points 97 and 98 of her Opinion, the General Court examined, in particular in paragraphs 185 to 188 of the judgment under appeal, the way in which ECHA and the MSC took some of those studies into consideration.

116    In so far as concerns the second complaint submitted in support of that part of the fourth ground of appeal, alleging, in essence, a contradiction between paragraphs 178 and 180 of the judgment under appeal, it must be held that that complaint is based on a misreading of those paragraphs. In fact, in paragraph 178 of that judgment, after having set out the appellants’ arguments that mere citation of the studies is not sufficient to demonstrate that ECHA took new information into account, the General Court found that the appellants had failed to cite any data for which it was impossible for them to know how they had been assessed. However, paragraph 180 addresses another argument, alleging manifest errors of assessment committed by ECHA in its assessment of certain studies. It is in that connection that the General Court held that the appellants had furnished examples which were intended to demonstrate that ECHA had not carefully examined the new information available to it, which examples were rejected by the General Court in the paragraphs subsequent to that paragraph 180.

117    In so far as concerns the third complaint alleging distortion vitiating paragraph 200 of the judgment under appeal, it is apparent from the procedural documents that the issue of the growth correction applied to the BCF values for D4 and D5 was not addressed by the appellants in the fifth part of the first plea in law relied upon at first instance. It is only in the reply lodged with the General Court, in particular in the part relating to the bioaccumulation of D6, as is stated in paragraph 201 of the judgment under appeal, that the appellants criticised ECHA for applying a growth-corrected BCF in the assessment of D4, D5 and D6.

118    Consequently, in paragraph 200 of the judgment under appeal, the General Court rightly rejected as out of time the appellants’ argument relating to an alleged growth correction of BCF values, even though that argument was raised in the reply and not solely at the hearing. As is clear from Article 84(2) of the Rules of Procedure of the General Court, new pleas in law may be introduced in the reply only where the condition laid down in Article 84(1) is met, namely that those pleas are to be based on matters of law or of fact which come to light in the course of the procedure, which the appellants failed to raise in the present case.

119    As regards the fourth complaint, alleging error in the assessment of the facts and of the appellants’ arguments relating to the potential contamination of samples examined in paragraph 208 of the judgment under appeal, it must be found, in the absence of any claim of distortion, that that complaint is inadmissible since, as has been recalled in paragraph 50 of the present judgment, the General Court has exclusive jurisdiction to find and appraise the relevant facts and to assess the evidence.

120    It follows that the second part of the fourth ground of appeal must be rejected as in part inadmissible and in part unfounded.

 The third part

–       Arguments of the parties

121    The appellants, supported by the ACC, submit, in the first place, that in paragraphs 96 and 225 of the judgment under appeal, the General Court wrongly departed from its own case-law, by ruling that Section 1.1.1.3 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation No 1907/2006 (OJ 2008 L 353, p. 1), is irrelevant for the purposes of the identification of PBT and vPvB substances. It is submitted that, in the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‑93/10, EU:T:2013:106), the General Court accepted that certain provisions of Regulation No 1272/2008 were applicable to the procedure for identifying a substance as being of very high concern.

122    In the second place, in paragraph 226 of the judgment under appeal, the General Court, it is argued, committed an error of assessment in so far as concerns the connection between the TMF and BMF data, and in so far as concerns the greater importance given to BCF values. The appellants thus reiterate, in essence, as regards D6 more particularly, their arguments put forward in the context of the first ground of appeal alleging misinterpretation of Annex XIII, in that the General Court gave priority to BCF data.

123    In the third place, in paragraphs 231, 234 and 237 of the judgment under appeal, the General Court, it is submitted, wrongly rejected as inadmissible the appellants’ objections with regard to the growth corrections applied in the CERI (2010) study, on the ground that those objections were only raised at the hearing. The appellants submit that, in actual fact, those objections were raised in their reply. The appellants also claim distortion of their arguments in paragraph 234 of the judgment under appeal, in that they did not dispute the validity of the methodology set out in OECD Guideline 305 in so far as concerns the growth correction applied by ECHA, but rather the application by ECHA of options provided for in that guideline in order to normalise growth.

124    In the fourth place, in paragraph 241 of the judgment under appeal, the General Court, it is argued, wrongly held that the appellants had stated that ECHA had to carry out a statistical analysis of the various studies on BCF data as a general practice. The appellants submit that they argued that ECHA had, in the weight-of-evidence determination, to take that information into consideration where it is available, as was the case in this instance, and give that information the importance it requires.

125    ECHA, supported by the Commission, contends that the third part of the fourth ground of appeal should be rejected. As regards, in particular, the application of Regulation No 1272/2008, the Commission takes the view that, in any event, the appellants’ line of argument is ineffective inasmuch as the weight-of-evidence determination was conducted by ECHA in compliance with Annex XIII.

–       Findings of the Court

126    In so far as concerns, in the first place, paragraphs 96 and 225 of the judgment under appeal, in which the General Court rejected the application by analogy of Section 1.1.1.3 of Annex I to Regulation No 1272/2008 – which contains an explanation of the weight-of-evidence determination similar to that set out in the second and third paragraphs of the preamble to Annex XIII – it should be held that the appellants have failed to demonstrate how a joint reading of the REACH Regulation and Regulation No 1272/2008 could have led to a conclusion other than that of the decision at issue, as the Advocate General also observes in paragraphs 71 and 72 of her Opinion. That argument must consequently be rejected as ineffective.

127    As regards, in the second place, the priority given to BCF data in comparison to BMF and TMF data in the identification of D6 as a bioaccumulative substance, it must be found that the General Court did not commit an error of interpretation in its finding, in paragraph 226 of the judgment under appeal, as to ‘the weight given to higher BCF values’. Accordingly, the appellants’ complaint in that connection must be rejected as unfounded. As regards the other aspects of the relationship between TMF and BMF data, it should be observed that the appellants merely advocate an interpretation of that relationship which differs from that adopted by the General Court without establishing the existence of any distortion.

128    In so far as concerns the complaint relating to the growth correction applied in the CERI (2010) study, while it is true that that complaint was essentially raised in the reply before the General Court and not only at the hearing, the fact remains that the rejection of that complaint as inadmissible as out of time, in paragraph 231 of the judgment under appeal, is not vitiated by any error of law, for the same reasons as those set out in paragraphs 117 and 118 of the present judgment.

129    As to the other complaints put forward by the appellants in relation to paragraphs 234, 237 and 241 of the judgment under appeal, it must he held that, by their arguments, the appellants merely dispute the weighing up of the evidence in the weight-of-evidence determination of the bioaccumulation of D6 without demonstrating the existence of the distortions alleged. They thereby seek, in reality, to obtain no more than a re-examination of the evidence produced before the General Court which, for the reasons set out in paragraph 50 of the present judgment, the Court of Justice does not have jurisdiction to undertake.

130    The third part of the fourth ground of appeal must, therefore, be rejected as being, in part, unfounded, in part, ineffective and, in part, inadmissible.

131    It follows from all the foregoing considerations that the appeal must be dismissed in its entirety.

 Costs

132    In accordance with Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to the costs. Under Article 138(1) of those rules, 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.

133    Under Article 184(4) of the Rules of Procedure of the Court of Justice, where the appeal has not been brought by an intervener at first instance, he or she may not be ordered to pay costs in the appeal proceedings unless he or she participated in the written or oral part of the proceedings before the Court. Where an intervener at first instance takes part in the proceedings, the Court may decide that he or she is to bear his or her own costs.

134    Under Article 140(1) of those Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs.

135    Since ECHA has requested that the appellants be ordered to pay the costs and since the appellants have been unsuccessful in their grounds of appeal, they should be ordered to pay the costs.

136    The Federal Republic of Germany and the Commission, interveners at first instance, are to bear their own costs.

137    Since the ACC, intervener at first instance, participated in the written part of the proceedings, it shall bear its own costs.

On those grounds, the Court (Fourth Chamber) hereby:

1.      Dismisses the appeal;

2.      Orders Global Silicones Council, Dow Silicones UK Ltd, Elkem Silicones France SAS, Evonik Operations GmbH, Momentive Performance Materials GmbH, Shin-Etsu Silicones Europe BV and Wacker Chemie AG to bear their own costs and to pay those incurred by the European Chemicals Agency (ECHA);

3.      Orders the Federal Republic of Germany, the European Commission and American Chemistry Council, Inc. (ACC) to bear their own costs.

Delivered in open court in Luxembourg on 9 November 2023.

*      Language of the case: English.

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