JUDGMENT OF THE GENERAL COURT (Eighth Chamber, Extended Composition)

30 June 2021 ( )

(REACH – Updating of Annex XVII to Regulation (EC) No 1907/2006 concerning restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles – Restrictions concerning octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) – Manifest error of assessment – Annex XIII to Regulation No 1907/2006 – Weight-of-evidence determination – Article 68 of Regulation No 1907/2006 – Unacceptable risk – Proportionality – Essential procedural requirements)

In Case T‑226/18,

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

Wacker Chemie AG, established in Munich (Germany),

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

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

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

represented by A. Kołtunowska and R. Semail, lawyers,

applicants,

supported by

American Chemistry Council, Inc. (ACC), established in Washington, represented by K. Nordlander and C. Grobecker, lawyers,

intervener,

v

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

defendant,

supported by

Federal Republic of Germany, represented by J. Möller, D. Klebs, S. Eisenberg, S. Heimerl and S. Costanzo, acting as Agents,

by

United Kingdom of Great Britain and Northern Ireland, represented by S. Brandon, acting as Agent, and by C. Banner and A. Parkinson, Barristers,

by

European Parliament, represented by L. Darie and A. Tamás, acting as Agents,

by

Council of the European Union, represented by M. Moore and A. Maceroni, acting as Agents,

and by

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

interveners,

APPLICATION under Article 263 TFEU for annulment of Commission Regulation (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation (EC) 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),

THE GENERAL COURT (Eighth Chamber, Extended Composition),

composed of S. Papasavvas, President, J. Svenningsen, R. Barents, T. Pynnä and J. Laitenberger (Rapporteur), Judges,

Registrar: B. Lefebvre, Administrator,

having regard to the written part of the procedure and further to the hearing on 29 September 2020,

gives the following

Judgment

I. Legal context

1 On 1 June 2007, 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) entered into force.

2 Annex I to Regulation No 1907/2006 (‘Annex I’) provides the following:

‘4. PBT AND VPVB ASSESSMENT

4.0. Introduction

4.0.1 The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.

4.0.2 The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report …:

Step 1: Comparison with the Criteria.

Step 2: Emission Characterisation.

…

4.1. Step 1: Comparison with the criteria

This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.

4.2. Step 2 Emission Characterisation.

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. …’

3 Annex I also provides the following:

‘6. RISK CHARACTERISATION

…

6.3. The risk characterisation consists of:

– a comparison of the exposure of each human population known to be or likely to be exposed with the appropriate DNEL,

– a comparison of the predicted environmental concentrations in each environmental sphere with the PNECs, and

– an assessment of the likelihood and severity of an event occurring due to the physicochemical properties of the substance.

…

6.5. For those human effects and those environmental spheres for which it was not possible to determine a DNEL or a PNEC, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario shall be carried out.

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses.’

4 Annex XIII to Regulation No 1907/2006 (‘Annex XIII’) lays down the criteria for the identification of persistent (‘P’), bioaccumulative (‘B’) and toxic (‘T’) substances (together, ‘PBT’), and very persistent (‘vP’) and very bioaccumulative (‘vB’) substances (together, ‘vPvB’).

5 On 15 March 2011, the European Commission adopted Regulation (EU) No 253/2011 amending Regulation No 1907/2006 as regards Annex XIII (OJ 2011 L 69, p. 7). That regulation amended the former Annex XIII, taking into account experience acquired at international level.

6 The preamble to Annex XIII now states:

‘This Annex lays down the criteria for the identification of persistent, bioaccumulative 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, 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 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.’

7 Annex XIII provides, inter alia:

‘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 5 000.’

8 Annex XIII also states the following:

‘3.2. Assessment Information

The following information shall be considered for the assessment of P, vP, 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, such as:

– Results from a bioaccumulation study in terrestrial species;

…

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

II. Background to the dispute

9 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, Wacker Chemie AG, Momentive Performance Materials GmbH, Shin-Etsu Silicones Europe BV and Elkem Silicones France SAS, are companies established in the European Union which manufacture, sell and supply silicone products, in particular the chemical substances octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’).

10 On 1 October 2014, the competent authority of the United Kingdom of Great Britain and Northern Ireland submitted to the European Chemicals Agency (ECHA) parts of a dossier based on Annex XV to Regulation No 1907/2006 (‘Annex XV’) relating to the PBT and vPvB properties of D4 and D5.

11 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.

12 Between 15 October and 1 December 2014, a public consultation took place regarding the documents provided by the United Kingdom relating to the PBT and vPvB properties of D4 and D5.

13 On 17 April 2015, the United Kingdom submitted to ECHA a dossier prepared in accordance with Annex XV (‘Annex XV dossier’) proposing a restriction on the use of D4 and D5 in cosmetic products that were washed off in normal conditions of use. According to that dossier, action on a Union-wide basis was necessary to address the risks to the environment posed by the use of D4 and D5 when discharged into waste water.

14 On 22 April 2015, the MSC adopted an opinion (‘the opinion of the MSC’) according to which both D4 and D5 met the criteria set out in Annex XIII regarding the identification of vP and vB substances.

15 Between 18 June and 18 December 2015, a public consultation took place on the envisaged restriction of the use of D4 and D5. As part of that public consultation, the applicants provided comments and submitted evidence.

16 On 10 March 2016, the ECHA Committee for Risk Assessment (‘the RAC’) adopted an opinion concluding, on the one hand, that D4 met the criteria set out in Annex XIII for the identification of PBT substances and vPvB substances and, on the other, that D5 met the criteria for the identification of vPvB substances (‘the opinion of the RAC’). The RAC confirmed that the hazard properties of D4 and D5 gave rise to specific concerns for the environment when those substances were present in cosmetic products used or disposed of with water. It also concluded that the proposed restriction was a targeted and appropriate Union-wide measure to minimise emissions caused by wash-off products.

17 On 11 March 2016, the ECHA Committee for Socio-economic Analysis (‘the SEAC’) in turn adopted a draft opinion. A public consultation took place between 16 March and 16 May 2016. On 9 June 2016, the SEAC adopted its final opinion, indicating that the proposed restriction was the most appropriate Union-wide measure for reducing the discharge of D4 and D5 to waste water in terms of its socio-economic benefits and costs (‘the opinion of the SEAC’). The SEAC nevertheless recommended that the application of the restriction be deferred for 24 months to allow stakeholders to take the measures necessary to comply with it.

18 On 10 August 2016, ECHA submitted the opinions of the RAC and the SEAC to the Commission.

19 On 10 May 2017, the Commission submitted its proposal for a regulation for consideration by the Committee established by Article 133 of Regulation No 1907/2006.

20 On 10 January 2018, the Commission adopted Regulation (EU) 2018/35 amending Annex XVII to Regulation (EC) No 1907/2006 as regards D4 and D5 (OJ 2018 L 6, p. 45; ‘the contested regulation’). That regulation provides that neither D4 nor D5 is to be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance, after 31 January 2020.

III. Procedure and forms of order sought

21 By application lodged at the Court Registry on 2 April 2018, the applicants brought the present action.

22 On 5 July 2018, the Commission lodged its defence at the Court Registry.

23 On 12 July 2018, the applicants, by separate document lodged at the Court Registry, requested that certain information in the file be treated as confidential vis-à-vis the public.

24 By documents lodged at the Court Registry on 16, 26, 27 July and 2 August 2018 respectively, the Council of the European Union, the Federal Republic of Germany, ECHA, the European Parliament and the United Kingdom applied to intervene in support of the form of order sought by the Commission.

25 By document lodged at the Court Registry on 2 August 2018, the American Chemistry Council Inc. (‘ACC’) applied to intervene in support of the form of order sought by the applicants.

26 By decision of 5 September 2018, the President of the Fifth Chamber of the General Court granted the Council, the Federal Republic of Germany, the Parliament and the United Kingdom leave to intervene.

27 On 22 September 2018, the applicants lodged their reply at the Court Registry.

28 On 25 September, 9 and 23 November 2018, the applicants, by separate documents lodged at the Court Registry, requested that certain information in the file be treated as confidential vis-à-vis ACC.

29 On 17 October 2018, the Council, the Federal Republic of Germany, the Parliament and the United Kingdom lodged their statements in intervention at the Court Registry.

30 By order of 25 October 2018, the President of the Fifth Chamber of the General Court granted ECHA’s application to intervene.

31 On 12 December 2018, the Commission lodged the rejoinder at the Court Registry.

32 On 12 December 2018, ECHA lodged its statement in intervention at the Court Registry.

33 By order of 13 December 2018, the President of the Fifth Chamber of the General Court granted ACC leave to intervene. He also ordered the Court Registry to provide ACC with a non-confidential version of the pleadings and documents lodged by all the parties. Finally, he decided it necessary to set a deadline for ACC, first, to submit its statement in intervention and, second, to provide its observations on the applicants’ request that the file be treated as confidential in its regard. By decision of 18 December 2018, those two deadlines were set at 30 January and 14 January 2019 respectively.

34 By documents lodged at the Court Registry on 17 and 18 January 2019 respectively, the Commission and the applicants submitted their observations on the statements in intervention of the Council, the Federal Republic of Germany, the Parliament and the United Kingdom. With regard, in particular, to the United Kingdom, the applicants requested that, after the withdrawal of that State from the European Union, it be denied any further involvement in the present case, as an intervener or otherwise. According to the applicants, at that date, that Member State would no longer have any specific rights as intervener or any legal interest in the result of the case.

35 On 30 January 2019, ACC lodged its statement in intervention at the Court Registry.

36 By documents lodged at the Court Registry on 1 and 4 February 2019 respectively, the Commission and the applicants each submitted their observations on ECHA’s statement in intervention.

37 By documents lodged at the Court Registry on 12 and 13 March 2019, respectively, the Commission and the applicants submitted their observations on ACC’s statement in intervention.

38 By letter of 2 April 2019, the applicants confirmed, at the Court’s request, that they were not requesting confidential treatment for the Commission’s observations on ACC’s statement in intervention. In addition, in anticipation of the withdrawal of the United Kingdom from the European Union, the applicants requested the Court to revoke, before the end of the written procedure, that Member State’s status as intervener and not to take its statement in intervention into account. Furthermore, as that Member State could no longer, according to the applicants, be regarded as a privileged applicant, it had to demonstrate an interest in bringing proceedings, which it failed to do. Finally, the applicants requested that that Member State be ordered to bear its own costs and to pay those incurred by the applicants in connection with its intervention in the proceedings.

39 By letter of 30 April 2019, the applicants requested that a hearing be held.

40 By decision of 23 October 2019 and following a change in the composition of the Chambers of the Court, the case was reassigned to a new Judge-Rapporteur sitting in the Eighth Chamber.

41 On 8 April 2020, the Court (Eighth Chamber), on a proposal from the Judge-Rapporteur and by way of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure of the General Court, put questions to the parties to be answered in writing. The parties complied with that request within the period prescribed.

42 On 20 April 2020, on a proposal from the Eighth Chamber, the Court decided, pursuant to Article 28 of the Rules of Procedure, to refer the case to a Chamber sitting in extended composition.

43 By measure of organisation of 7 May 2020, the main parties were asked whether or not, in the light of the health situation connected to COVID-19, they were maintaining their request to be heard at a hearing. By letter of 29 May 2020, the applicants stated that they were maintaining that request.

44 On 7 August 2020, the Court (Eighth Chamber, Extended Composition), acting on a proposal from the Judge-Rapporteur and by way of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, invited each of the parties to submit its observations on the other parties’ replies to the Court’s written questions of 8 April 2020. The main parties, as well as the United Kingdom and ECHA, complied with that request within the period prescribed.

45 On a proposal from the Judge-Rapporteur, the Court (Eighth Chamber, Extended Composition) decided to open the oral part of the procedure.

46 The parties, with the exception of the United Kingdom, which did not participate in the hearing, presented oral argument and answered the questions put to them by the Court at the hearing on 29 September 2020.

47 At the hearing, the applicants withdrew two of their heads of claim based on a plea of illegality, which was recorded in the minutes of the hearing, such that they now claim that the Court should:

– annul the contested regulation;

– order the Commission to pay the costs;

– take any other measure as justice may require.

48 The Commission contends that the Court should:

– declare the action inadmissible in so far as it concerns preparatory and non-binding acts;

– dismiss the action as unfounded as to the remainder;

– order the applicants to pay the costs.

49 The Council contends that the Court should:

– dismiss the action as unfounded;

– order the applicants to pay the costs.

50 The Federal Republic of Germany requests the Court to dismiss the action.

51 The Parliament, having taken note of the applicants’ withdrawal of the head of claim based on the plea of illegality in respect of Annex XIII or certain of its provisions, states that it no longer has any claims.

52 The United Kingdom claims that the Court should:

– declare the action inadmissible in so far as it concerns preparatory and non-binding acts;

– dismiss the remainder of the action as unfounded.

53 ECHA contends that the Court should:

– declare the action inadmissible in so far as it concerns preparatory and non-binding acts;

– dismiss the action as unfounded as to the remainder;

– order the applicants to pay the costs.

54 ACC requests the Court to uphold the action as well founded.

IV. Law

A. Intervention of the United Kingdom

55 In their observations on the United Kingdom’s statement in intervention of 18 January 2019 and in their letter of 2 April 2019, the applicants, in essence, requested the Court to revoke the status as intervener accorded to that former Member State given that it had withdrawn from the European Union.

56 In that regard, it should be noted that, until the date of delivery of the present judgment, the United Kingdom had a right to intervene.

57 Indeed, when it was authorised to intervene by decision of the President of the Chamber of 5 September 2018, the United Kingdom was still a Member State of the European Union. Consequently, its right to intervene stemmed from a direct application of the first paragraph of Article 40 of the Statute of the Court of Justice of the European Union.

58 After its withdrawal from the European Union and during the transition period, as defined by Article 126 of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, as approved by Council Decision (EU) 2020/135 of 30 January 2020 on the conclusion of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ 2020 L 29, p. 1) (‘the Withdrawal Agreement’), ending on 31 December 2020, the first paragraph of Article 40 of the Statute of the Court of Justice of the European Union continued to apply to the United Kingdom in accordance with Article 127(1) and (6) of the Withdrawal Agreement, according to which, during that transition period, EU law was applicable to the United Kingdom and according to which, unless otherwise provided in the Withdrawal Agreement, any reference to Member States in that law was to be understood as including the United Kingdom.

59 Thus, during the written and oral part of the procedure, the United Kingdom continued to enjoy intervener status under the first paragraph of Article 40 of the Statute of the Court of Justice of the European Union.

60 Contrary to what the applicants claim in their observations on the replies of the Commission and of the United Kingdom to a question from the Court, a breach of the Withdrawal Agreement by the United Kingdom, if established, would not prevent that State from invoking the rights arising from that agreement. Neither EU law nor, more specifically, the Withdrawal Agreement contains a general provision according to which one of the parties automatically loses its rights under EU law and the Withdrawal Agreement in the event of breach of one of its obligations.

61 So far as concerns the period after the transition period, it must be held that, as the United Kingdom submits, even assuming that, since 1 January 2021, that State – now a third country – can no longer rely on the first paragraph of Article 40 of the Statute of the Court of Justice of the European Union, that State would, in any event, establish an interest in the result of the case within the meaning of the second paragraph of Article 40 of that statute, given that it was the competent authority of that State which had submitted to ECHA parts of an Annex XV dossier relating to the PBT and vPvB properties of the substances D4 and D5.

B. Substance

62 Following the withdrawal, at the hearing, of two of their heads of claim, the applicants rely, in support of their action, in essence, on eight pleas in law.

63 The first plea alleges manifest errors of assessment.

64 The second plea alleges breach of the principle of proportionality, in that the contested regulation is not appropriate or necessary to address the purported concern, does not constitute the least onerous measure and causes disadvantages which are disproportionate to the aims pursued.

65 The third plea alleges breach of essential procedural requirements, in particular in that the Commission ‘never adequately or sufficiently considered or reviewed the fundamental basis for the contested [regulation]’. Moreover, according to the applicants, it is the RAC – and not the MSC – that should have assessed all the underlying factors and justifications for the restriction established by the contested regulation.

66 The fourth plea alleges breach of the principle of legal certainty and of the principle of legitimate expectations.

67 The fifth plea alleges breach of the institutional balance of powers, in that ECHA ‘made law’ in reaching a conclusion on the B and vB properties of D4 and D5, outside and independently of the applicable law.

68 The sixth plea alleges breach of the principle of good administration, in particular in that the Commission and ECHA breached the requirement to ensure that administrative procedures in risk assessments ensure scientific objectivity and preclude arbitrary measures.

69 The seventh plea alleges breach of the rights of the defence and of the right to be heard.

70 Finally, the eighth plea alleges breach of the obligation to state the reasons for the contested regulation.

1. First plea in law: manifest errors of assessment

71 The applicants, supported by ACC, submit in essence that, in adopting the contested regulation, the Commission committed a number of manifest errors of assessment.

72 The Commission, supported by the Federal Republic of Germany, the United Kingdom and ECHA, contends that the first plea should be rejected as unfounded.

73 It should be noted that the contested regulation was adopted on the basis of Article 68(1) of Regulation No 1907/2006. As is apparent from Article 1(1) of Regulation No 1907/2006, the purpose of that 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. According to recitals 87, 89 and 91 of Regulation No 1907/2006, the EU legislature set as the main purpose of the introduction of new restrictions and the amendment of existing restrictions, as provided for in Title VIII of that regulation, the first of those three objectives, namely ensuring a high level of protection of human health and the environment (see judgment of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 62 and the case-law cited).

74 In order to be able to pursue those objectives effectively, it must be emphasised that, in an area of evolving and complex technology such as that of the present case, the competent EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts, in order to determine the nature and scope of the measures which they adopt. Thus, in that area, review by the European Union judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the authorities of the European Union on which alone the FEU Treaty has placed that task (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).

75 Moreover, the broad discretion of the authorities of the European Union, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the European Union authorities which have adopted the act in question must be able to show before the European Union judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 53 and the case-law cited).

76 It is thus for the European Union judicature to establish inter alia whether the evidence relied on contains all the information which must be taken into account in order to assess the complex situation at issue (see judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 87 and the case-law cited).

77 In essence, the present plea can be broken down into four parts. The first part refers to the existence of errors allegedly committed in the hazard assessment and in the identification of D4 and D5 as PBT and vPvB or vPvB substances pursuant to Annex XIII. In the second part, the applicants claim that the contested regulation does not comply with one of the conditions laid down for the adoption of a restriction, defined in Article 68(1) of Regulation No 1907/2006, namely that unacceptable risk results from ‘the manufacture, use or placing on the market’ of a substance. In the third part, they argue that a number of errors were made in the risk assessment. The fourth part of the first plea concerns the arguments of the applicants raised also under the plea alleging breach of essential procedural requirements according to which the Commission ‘never adequately or sufficiently considered or reviewed the fundamental basis for the contested [regulation]’.

(a) First part of the first plea: manifest error of assessment in the hazard assessment and in the identification of D4 and D5 as PBT and vPvB or vPvB substances pursuant to Annex XIII

78 The applicants, supported by ACC, claim that the application of the weight-of-evidence determination according to the rules laid down in Annex XIII is vitiated by manifest errors. D4 and D5 do not present any hazards and are neither PBT substances nor vPvB substances. The identification of D4 as a PBT and vPvB substance and of D5 as a vPvB substance is vitiated by manifest errors of assessment.

(1) The allegedly insufficient consideration of factors other than the bioconcentration factor

79 The applicants claim, first of all, that ECHA and the Commission committed a manifest error of assessment in relying, in the identification of the vB properties of D4 and D5, solely on the bioconcentration factor (‘BCF’), to which Sections 1.1.2 and 1.2.2 of Annex XIII refer, and ignoring other factors, such as the trophic magnification factor (‘TMF’) and the biomagnification factor (‘BMF’). The Executive Director of ECHA requested an opinion from the MSC ‘on whether the relevant properties of D4 and D5 [met] the criteria for being persistent or very persistent or bioaccumulative or very bioaccumulative in Annex XIII of REACH’. Thus, the Executive Director did not request the MSC to provide a scientifically objective, valid, robust and independent opinion on the basis of a weight-of-evidence assessment.

80 According to the applicants, even if it were to be considered that the TMF and the BMF were taken into account, the fact remains that they were attributed less importance than the BCF, even though TMF and BMF are critical factors in determining the B and vB properties of a substance. The importance of information on the TMF and the BMF is reflected in Section 3.2.2(c) of Annex XIII. In the applicants’ opinion, trophic magnification and biomagnification up the food chain were the most reliable factors for assessing whether D4 and D5 were B or vB substances. Consequently, the legal or scientific weight attributed to TMF, BMF and bioaccumulation factor data was insufficient in relation to their actual scientific importance. ACC argues that, in accordance with recitals 5 and 6 of Regulation No 253/2011, a weight-of-evidence determination was particularly relevant in the present case because TMF data and other data have shown that D4 and D5 do not biomagnify to unpredictable concentrations in the food web.

81 According to the applicants, in complying with its guidance, whereby an ‘indication of a biomagnification potential can on its own be considered as a basis to conclude that a substance meets the B or vB criteria’, ECHA did not attribute to the scientific data weight commensurate with their actual scientific validity. ECHA attributed weight to studies that could indicate biomagnification potential when it attributed ‘lesser weight, and/or not relevant legal weight, to studies such as, for example, the Powell et al study’.

82 According to the applicants, due to the importance of the BMF, it was important to determine a threshold limit by using the TMF/BMF metric to identify a substance as B or vB. That was not done by the MSC. In their view, therefore, there was no system for comparing, on the one hand, the ‘strength’ of the TMF and BMF data and, on the other hand, the BCF and other data.

83 The Commission, supported by the Federal Republic of Germany, the United Kingdom and ECHA, disputes those arguments.

84 As regards, in the first place, the applicants’ assertion that the MSC did not take into account data other than the BCF, in particular TMF and BMF data, it is clear from the file and from the opinion of the MSC that the MSC did indeed take other data into account. After all, the MSC inter alia examined data relating to the BMF, noted variable results concerning the field data on biomagnification and the TMF, considered the reasons for those variations and concluded that those data were inconclusive, but that certain of the trophic magnification studies supported the conclusion that D4 and D5 were bioaccumulative. The MSC found that the information on the BMF and the TMF available on the ground, which indicated that biodilution had occurred in some food chains, did not invalidate the other lines of evidence. Last, the MSC concluded that D4 and D5 were vB substances on the basis of BCF data supported by multiple sources of data on biomagnification.

85 Consequently, it is appropriate to reject that argument of the applicants on the ground that it is factually incorrect.

86 As regards, in the second place, the applicants’ arguments that too much legal weight was attributed to the BCF when the TMF and the BMF are the crucial factors for determining the B property, it must be stated that the EU legislature chose to lay down, in Sections 1.1.2 and 1.2.2 of Annex XIII, the criteria for identifying B or vB substances by reference to their BCF in aquatic species. According to the third paragraph of the preamble to Annex XIII, the information listed in Section 3.2, in particular the results of a study on the bioconcentration or bioaccumulation of a substance in aquatic species and the information on the ability of that substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors, is to be compared with the criteria set out in Section 1 of that annex on the basis of a weight-of-evidence determination using expert judgement.

87 According to the second paragraph of the preamble to Annex XIII, the weight-of-evidence determination is to be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information. A BCF resulting from a reliable study on the bioconcentration of a substance in aquatic species, such as that at issue in the present case, may be directly – that is to say, numerically – compared with the criteria laid down in Sections 1.1.2 and 1.2.2 of Annex XIII. While recognising that this does not preclude the application of the weight-of-evidence determination in cases like the present one, in which BCF data are available and relevant, it is clear that the information and data referred to in Section 3.2.2 of Annex XIII gain in importance in particular when the criterion defined by reference to the BCF cannot be applied directly to the information available. Contrary to what ACC suggests in its statement in intervention, it is not apparent from recitals 5 and 6 of Regulation No 253/2011 that the weight-of-evidence determination is particularly relevant when the TMF data and other data show that a substance does not biomagnify to unpredictable concentrations in the food web. Recital 6 of that regulation, like the second paragraph of the preamble to Annex XIII, refers to the impossibility of directly applying the criteria in Section 1 to the information available. Where reliable BCF information is available, the criteria established by reference to the BCF may be applied to that information directly.

88 It follows from those provisions that the legislature chose to give a certain priority to the results of reliable studies on the BCF of a substance in aquatic species or, at the very least, that the MSC, without committing a manifest error of assessment, considered that the BCF values had, in the case at hand, greater weight than the other data cited by the applicants.

89 By contrast, the arguments raised by the applicants, based on the alleged greater importance of other information in the case, such as TMF and BMF information, find no support in the text of Annex XIII and, in particular, do not take that priority into account. They are thus based on a misinterpretation of the relevant provisions of that annex.

90 Moreover, the applicants have not demonstrated that the assessment and conclusion of the MSC on the vB properties of D4 and D5 in the present case were not in conformity with those provisions or were vitiated by manifest errors of assessment. It has already been noted that the MSC inter alia examined data relating to the BMF, noted variable results concerning the field data on biomagnification and the TMF, considered the reasons for those variations and concluded that those data were inconclusive, but that certain of the trophic magnification studies supported the conclusion that D4 and D5 were bioaccumulative. The MSC found that the information on biomagnification and the TMF available on the ground, indicating that biodilution had occurred in some food chains, did not invalidate the other lines of evidence. Furthermore, the MSC referred to Chapter R.11 on the evaluation of the PBT properties of November 2014 of ECHA’s ‘Guidance on Information Requirements and Chemical Safety Assessment’ (‘the ECHA Guidance’), as a consolidated source of expert opinion, according to which the absence of biomagnification cannot be used to disregard a valid assessment based on reliable BCF data indicating that a substance meets the criteria for B and vB substances set out in Annex XIII. Last, the MSC concluded that D4 and D5 were vB substances on the basis of BCF data supported, inter alia, by multiple lines of evidence on biomagnification resulting from dietary testing. Thus, the MSC did indeed apply a weight-of-evidence determination using expert judgement, as provided for in Annex XIII, by comparing the available and relevant information referred to in Section 3.2.2 of that annex to the criterion laid down in Section 1.2.2.

91 The fact that the MSC thus attributed greater weight to the BCF values in the case at hand does not constitute a manifest error of assessment. On the contrary, that committee acted in accordance with Annex XIII and complied with the order set out by the EU legislature.

92 ECHA, the United Kingdom and the Federal Republic of Germany also state – rightly – that that also corresponds to the greater scientific weight of the BCF. Thus, BCF is given the ‘greatest weight’ as the preferred metric because it follows, as the main result, from a standard test for bioaccumulation in fish, namely Guideline No 305 of the Organisation for Economic Cooperation and Development (OECD) Guidelines for the Testing of Chemicals (‘OECD Guideline No 305’), which is recognised as the most robust test for measuring bioaccumulative potential in general.

93 With regard to the applicants’ arguments, set out in their observations on the statement in intervention submitted by ECHA, according to which neither that guideline nor the other arguments advanced by the Commission and ECHA demonstrate that BCF was an appropriate metric for measuring the bioaccumulative potential of D4 and D5 since those two substances have unique physicochemical properties, the following must be stated. First, OECD Guideline No 305 is of general application and does not provide for any exceptions to application for substances such as D4 or D5. Second, it is apparent from Annex XIII, in particular from Sections 1.1.2 and 1.2.2 thereof, that the BCF in aquatic species is, in general, not only an appropriate instrument, but also the main instrument prescribed by Regulation No 1907/2006 for measuring bioaccumulative potential. Third, the question whether Annex XIII, in particular Sections 1.1.2 and 1.2.2 thereof, was applicable in the present case and whether the allegedly unique properties of D4 and D5 call into question the conclusion on the vB properties of those substances will be examined in paragraph 99 et seq. below and in paragraph 113 et seq. below, respectively.

94 Likewise, the fact that the MSC found that the information indicating biodilution in certain food chains did not invalidate the other lines of evidence does not constitute a manifest error of assessment. As was indicated in Chapter R.11 of the ECHA Guidance, to which the MSC referred:

‘… as dietary and trophic biomagnification represent different processes than bioconcentration in aquatic organisms, BMF and/or TMF values <1 cannot be used to disregard a valid assessment based on reliable BCF data indicating that a substance meets the numerical B/vB criteria in Annex XIII. … In principle, BMF values are not directly related to the BCF values, and in fact BMFs and BCFs represent complementary bioaccumulation pathways. Food chain transfer and secondary poisoning are basic concerns in relation to PBT and vPvB substances, therefore an indication of a biomagnification potential can on its own be considered as a basis to conclude that a substance meets the B or vB criteria but absence of such a biomagnification potential cannot be used to conclude that these criteria are not fulfilled. …’

95 That assessment does not depart from the provisions of Annex XIII. Given that bioconcentration and biomagnification are two different pathways to bioaccumulation, both explicitly recognised by Annex XIII, it is clear that the mere absence of biomagnification does not mean that there is no bioaccumulation. Consequently, even the existence of biodilution does not necessarily, according to Annex XIII, dispel the concerns arising from bioconcentration. Thus, and contrary to what the applicants submit, even the identification of a vB substance on the basis of reliable BCF data meeting the criteria laid down in Sections 1.1.2 and 1.2.2 of Annex XIII in the absence of studies proving biomagnification or trophic magnification does not constitute a manifest error of assessment.

96 Moreover, the applicants have failed to prove that the existence of biodilution in certain food chains rules out biomagnification in other food chains.

97 In any event, in the case at hand, the MSC found that the field data on biomagnification and on the trophic magnification of D4 and D5 were inconclusive. Therefore, it is without committing a manifest error of assessment that the MSC was able to find that a conclusion on bioconcentration, based on reliable studies showing BCF values meeting the criteria of vB substances laid down in Annex XIII and which were therefore conclusive, was not invalidated by data which, for their part, did not allow for any definitive conclusion to be drawn on biomagnification and on the trophic magnification of those substances.

98 Last, contrary to what the applicants suggest, the mere fact that the MSC presented certain considerations and conclusions relating to the bioaccumulation of D4 and D5 together does not mean that data and studies relating to D5 were considered applicable to D4 despite the differences between the two substances. That assertion – in support of which the applicants do not provide any concrete examples – is, moreover, undermined by the fact that the MSC, in its opinion of 22 April 2015, clearly distinguishes between the two substances.

(2) Application of the criteria laid down in Sections 1.1.2 and 1.2.2 of Annex XIII

99 The applicants claim that factors other than the BCF were particularly important and that the criteria laid down in Sections 1.1.2 and 1.2.2 of Annex XIII, which specifically refer to the BCF, should therefore have been adjusted in this case for their application to D4 and D5. That follows more particularly, according to the applicants, from the fact that those substances have inorganic backbones, which drives unique properties. Moreover, it is apparent, in their view, from the last paragraph of the preamble to Annex XIII, according to which that annex ‘shall apply to all organic substances, including organo-metals’, that Section 1 of Annex XIII was not intended to apply and does not apply to inorganic or predominantly inorganic substances, such as D4 and D5.

100 In the reply, the applicants state that neither D4, D5 nor, more generally, siloxanes are listed in the Blue Book of the International Union of Pure and Applied Chemistry (IUPAC) on organic substances (‘the Blue Book’), a collection of recommendations on the nomenclature of organic compounds. D4 and D5 are no different from polysiloxanes, since they exhibit the same basic chemical structure (Si-O inorganic backbone) and the same organic (methyl) lateral chains. Polysiloxanes are defined in the Gold Book, a collection of definitions of chemical terms, as ‘inorganic polymers’ and are considered by ECHA to be inorganic substances. Moreover, ISO standards distinguish between polymers and silicone plastic. However, in their observations on the report for the hearing, the applicants indicate that, even though it is incorrect to state that D4 and D5 are no different from polysiloxanes, D4 and D5 belong to the same family as siloxanes and polysiloxanes.

101 The applicants are of the view that there are substantial data on the inorganic nature of D4 and D5.

102 The Commission, supported by the Federal Republic of Germany and ECHA, disputes those arguments and contends that the provisions of Annex XIII were applicable to D4 and D5.

103 In that regard, it should be recalled that the sixth paragraph of the preamble to Annex XIII states that that annex is to apply to all organic substances, including organo-metals. In contrast to its previous version, the version of Annex XIII applicable in the present case no longer contains an express declaration concerning its non-application to inorganic substances, as the Commission rightly points out.

104 Moreover, it is appropriate to reject the applicants’ line of argument according to which the scope of that annex was not changed and could not be changed by the Commission without having due regard to the need to change also the criteria for B and vB substances owing to the broadening of that scope. First, the current wording of the preamble to Annex XIII defines the applicability of that annex to organic substances, including organo-metals, in a positive manner, whereas its previous wording explicitly excluded its applying to inorganic substances. Second, the change in the wording of the preambular paragraph in question would be difficult to understand, as to the legislature’s intention, if no change to its scope were to result from it. Third, the allegedly limited competence of the Commission to amend that annex is in no way apparent from the applicable provisions, in particular those of Articles 131 and 133(4) of Regulation No 1907/2006.

105 Consequently, even a substance with a ‘hybrid’ structure, namely an organic-inorganic or ‘principally inorganic’ structure, which, according to the applicants, is the case for D4 and D5, would not necessarily be excluded from the scope of that annex.

106 Furthermore, it should be noted that the Blue Book states that structures ‘containing at least one carbon atom and no element from Groups 1-12’ are organic compounds. D4 and D5 contain multiple carbons and elements from Groups 14 and 16 of the periodic table, as the Commission contends, without being contradicted on that point by the applicants. Cyclosiloxanes, such as D4 and D5, are also defined in the Gold Book as compounds having rings of alternating silicon and oxygen atoms. The entry relating to cyclosiloxanes in the Gold Book contains a reference to the ‘Glossary of class names of organic compounds and reactive intermediates based on structure (IUPAC Recommendations 1995)’.

107 It is apparent from those publications that the classification of D4 and D5 as organic substances appears to be consistent with internationally recognised terminology.

108 None of the arguments raised by the applicants is capable of demonstrating that D4 and D5 are inorganic substances, or that Annex XIII or the criteria for vB substances which are defined therein did not apply to those substances.

109 First, as regards the arguments alleging that polysiloxanes are recognised in the Gold Book as being inorganic polymers, it must be held that none of the evidence submitted supports the view that D4 and D5 are polysiloxanes or that the classification of those two substances must correspond to that of polysiloxanes. The applicants have merely provided extracts making reference to polysiloxanes or to hybrid or inorganic polymers. However, it is apparent from the definition of polysiloxanes according to which they constitute ‘inorganic polymers’, to which the applicants refer, that polysiloxanes are defined in the international nomenclature as polymers. As the Commission submits, D4 and D5 are not defined as polymers either according to the definition in Article 3(5) of Regulation No 1907/2006 or according to the IUPAC nomenclature, which is not disputed by the applicants. Consequently, it must be held that, according to that nomenclature, D4 and D5 are not regarded as polysiloxanes. Likewise, the fact that polysiloxanes are inorganic polymers does not mean that D4 and D5 must be regarded as hybrid or even inorganic substances.

110 Second, in their replies to the questions put by the Court, the applicants claimed that the fact that a substance was mentioned in the Blue Book could not mean that all substances belonging to that family were to be regarded as organic substances. In that regard, suffice it to note that that argument also fails to demonstrate that D4 and D5 should not be regarded as organic substances. More generally, the fact that the applicants disagree with the terminology and nomenclature established in the Blue Book and the Gold Book to which the Commission has referred is irrelevant. In any event, the European Union authorities cannot be criticised for relying on that terminology established by the IUPAC, the task of which is, inter alia, to define a generally recognised nomenclature and terminology.

111 Third, in their replies to the questions put by the Court, the applicants assert that the designation of the substances at issue in the Blue Book has no impact on the behaviour of those substances, which is determined by their organic chain. In that regard, suffice it to note that, according to the sixth paragraph of the preamble to Annex XIII, that annex is to apply to organic substances and that that argument is not such as to call into question the classification of D4 and D5 as such substances. The question whether the allegedly unique properties of D4 and D5 ought to have had an impact on the conclusion relating to their vB properties is examined in paragraph 118 et seq. below.

112 It follows that the applicants’ arguments relating to the application of Annex XIII and the criteria laid down in Sections 1.1.2 and 1.2.2 thereof must be rejected.

(3) The allegedly inadequate assessment of the allegedly unique properties of D4 and D5 such as their volatility, their low water solubility, their metabolisation by certain organisms and their trophic dilution

113 The applicants claim that D4 and D5 are not bioaccumulative, given that they are volatile, poorly soluble in water and not found in natural surface waters. The applicants stated before the adoption of the contested regulation that, inter alia for those reasons, the numeric criteria provided for in Annex XIII were not suitable for assessing the real-life behaviour of the substances at issue. The applicants maintain in the reply, by reference to certain studies annexed to it, that, due to those physicochemical properties, the reversibility of D4 and D5 is shorter than that of PBT and vPvB substances.

114 Moreover, D4 and D5 are metabolised by benthic organisms and terrestrial and other air-breathing organisms, which prevents accumulation.

115 Consequently, D4 and D5 do not biomagnify in food webs and are more subject to trophic dilution.

116 At the hearing, the applicants stated that the BCF tests relating to D4 and D5 did not take into account either those intrinsic properties or the environmental conditions in which organisms interacted with those substances, in particular in that any possibility of the substance of leaving water had wrongly been excluded. Consequently, the data were not obtained under ‘relevant conditions’.

117 The Commission, supported by the Federal Republic of Germany and ECHA, disputes those arguments.

118 In the first place, it should be emphasised that Annex XIII describes the criteria for the identification of PBT and vPvB substances for all organic substances, including organo-metals. The EU legislature chose to establish the criteria for identifying a substance as a vB substance by reference to its BCF in aquatic species, while taking international standards into account. By their arguments, according to which those rules were not appropriate for measuring the real-life bioaccumulation of D4 and D5, the applicants are in fact arguing that the criteria as defined by the legislature, in general terms, should not have been applied in this case, in view of its particularities.

119 In the second place, it is appropriate to reject the applicants’ contention that, due to the allegedly unique properties of D4 and D5, those substances, once discharged into the environment, are not found in water, which excludes any bioaccumulation in real-life situations. Without it being necessary to rule on the question whether a given degree of presence in the environment constitutes an aspect relevant to the assessment provided for in Annex XIII, that contention is not supported by any element in the file. It is apparent from the file and in particular from pages 20 and 21 of the opinion of the MSC that D4 and D5 are found in a wide range of organisms, particularly in fish and aquatic invertebrates, but also in birds and mammals up and down various aquatic food chains, including in large predators. As the Commission rightly submits, a low water solubility does not mean that a substance is not at all present in water or that there is no bioconcentration in aquatic species.

120 In the third place, as regards the argument based on the allegedly unrealistic conditions under which the BCF tests were carried out, it should be recalled that, according to Article 13(3) of Regulation No 1907/2006, where tests on substances are required to generate information on intrinsic properties of substances, they are to be conducted in accordance with the test methods laid down in a Commission regulation or in accordance with other international test methods recognised by the Commission or ECHA as being appropriate. Thus, the concept of ‘relevant conditions’ under which the data must be obtained, in accordance with the fourth paragraph of the preamble to Annex XIII, covers, inter alia, testing conditions as provided for in the test methods referred to in Article 13(3) of Regulation No 1907/2006.

121 The applicants do not claim that the BCF tests were not carried out in accordance with the requirements arising from OECD Guideline No 305, but they do assert that those tests are not in conformity with best scientific practice in that they do not take into account the properties of the substances at issue and do not reproduce environmental conditions. However, the reliability of the studies at issue cannot be invalidated solely on the basis of that criticism by the applicants, which in fact calls into question, without any tangible evidence, the scientific validity of OECD Guideline No 305. As regards the alleged failure to take into account intrinsic properties, as ECHA has explained, it is necessary to maintain a stable concentration in water during the test in order to be able to calculate the BCF. Moreover, ECHA cannot be criticised for following the OECD guidance document on the testing of difficult substances. As regards, more generally, the allegedly unrealistic conditions recommended for testing, OECD Guideline No 305 does not require the same conditions to be reproduced in a laboratory as those which exist in the environment. First, there are a multitude of conditions in the environment which may differ considerably from one place to another. Second, such environmental conditions may make it more difficult to measure the intrinsic property in question in order to compare it with results concerning other substances or a relevant threshold, for example the criterion laid down for the identification of vB substances, as is set out in Annex XIII. The very reason for establishing standards such as that guideline is to ensure the objectivity and comparability of results relating to a specific intrinsic property of a substance, such as the vB property. In particular, the fact that the concentration of a substance in water during testing may differ from its concentration in certain places in the environment has no bearing on the reliability of the results. What is more, as has been stated by ECHA, the BCF is a ratio comparing concentrations in the organism with those in its environment and not an absolute value. Thus, the presence of a substance in the environment is sufficient for bioconcentration to occur, even if the concentration of the substance at issue is low, or even lower than during testing.

122 In the fourth place, it should be noted that all the physicochemical properties of D4 and D5 mentioned by the applicants were taken into account in the MSC’s assessment of P and vP properties and of B and vB properties. First, it is stated on pages 3 and 5 of the opinion of the MSC, for example, that D4 and D5 are poorly soluble, volatile substances and that they have high adsorption potential. Second, it is apparent from the opinion of the MSC that the low water solubility of D4 and D5 was taken into account during the laboratory tests, in accordance with the scientific requirements and OECD Guideline No 305, as the Commission submits in its replies to the Court’s questions. Third, as the Commission rightly points out, the MSC, in its opinion, examined in detail the role of metabolism in bioaccumulation potential (see pages 16 and 17 of the opinion).

123 The applicants have not shown how that consideration is vitiated by manifest errors of assessment.

124 As regards, more specifically, the argument based on the metabolism and trophic dilution of D4 and D5, the applicants again appear to claim that the information relating to biomagnification and trophic magnification should have prevailed over the information relating to the BCF in aquatic species. In that regard, it is appropriate to recall that it has already been established (in paragraph 86 et seq. above) that it is in accordance with the provisions of Annex XIII and without committing a manifest error of assessment in that regard that the MSC based its conclusion on data of the BCF in aquatic species supported by information on biomagnification resulting from dietary testing. It should be emphasised that the MSC acknowledged the existence of information indicating the existence of biodilution in certain food chains. Nevertheless, it concluded, without committing a manifest error of assessment and in accordance with the provisions of Annex XIII, that that information did not invalidate the other evidence. It also found that certain studies on trophic magnification supported the conclusion that D4 and D5 were bioaccumulative. Consequently, that argument of the applicants must be rejected.

125 In the fifth place, as regards the studies provided by the applicants in annex to the reply, first, it must be pointed out that the applicants do not state how those studies support their argument that, due to their unique nature, D4 and D5 are more reversible in the environment, particularly in sediment, than PBT and vPvB substances. They merely make a general reference to those annexes. It is not for the Court, however, to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 94). In any event, the EU legislature laid down clear criteria in Annex XIII for the identification of PBT and vPvB substances. That annex reflects the legislature’s view that a substance which meets the criteria for identifying PBT or vPvB substances is of very high concern. The legislature did not provide for any additional assessment for substances meeting those criteria with a view to ascertaining whether they are more or less ‘reversible’ than other PBT and vPvB substances. Incidentally, ECHA has indicated, without being contradicted on the point by the applicants, that the Xu and Wania (2013) study was indeed taken into account by the RAC, that the study by Mackay et al. (2014) had not been submitted during the public consultation and that the two Kim et al. studies were published after the opinions of the MSC and of the RAC and thus could not be taken into account. ECHA has also stated the reasons for which, in its view, the study by Mackay et al. (2014) and the two Kim et al. studies do not support the applicants’ argument. On that point, the applicants merely reiterate their argument that the volatility and degradation of the substances at issue mitigate the persistency of those substances in all environments, without indicating how those studies support that argument.

126 In the light of the foregoing and having regard to the findings in paragraphs 74 and 75 above, it cannot be held that the contested regulation is vitiated by a manifest error of assessment on account of the allegedly unique physicochemical properties of D4 and D5.

(4) The fact that PBT and vPvB properties were identified in different compartments

127 The applicants claim that ECHA committed a manifest error of assessment in examining the alleged P, B and T properties of D4 and D5 in isolation instead of examining them together. They submit, inter alia, that B properties were not identified in the same compartment as P properties. The information used for the purposes of the assessment was thus not based on relevant data, which is contrary to the requirements of the fourth paragraph of the preamble to Annex XIII. In particular, the assessment of the vP and vB properties of D4 and D5 did not observe the requirements provided for in the fourth paragraph of Annex XIII, such that vP properties, on the one hand, and vB properties, on the other, were identified on the basis of information falling within different compartments.

128 The Commission, supported by the Federal Republic of Germany, the United Kingdom and ECHA, disputes those arguments.

129 In that regard, it must be stated that Annex XIII, as the Commission rightly contends, does not require the two or three criteria all to be met in one and the same compartment for the following reasons.

130 First, only the criteria for identifying P and vP properties set out in Sections 1.1.1 and 1.2.1 of Annex XIII expressly refer to specific compartments, such as the various types of water, the sediments of different water types and soil, and define different criteria and alternative criteria for various compartments. Sections 1.1.2, 1.1.3 and 1.2.2 of Annex XIII, which define the criteria for identifying B, vB or T substances, do not make any express reference to a specific compartment and, above all, do not establish a link between such a compartment and the compartment in which P properties were identified. Furthermore, the criteria for identifying B and vB substances laid down in Sections 1.1.2 and 1.2.2 of Annex XIII are established by reference to the BCF in aquatic species and therefore fall within a specific compartment which does not correspond to all the compartments by reference to which the criteria for identifying P and vP substances are laid down in Sections 1.1.1 and 1.2.1 of that annex. The applicants’ line of argument would obviate, for example, the criteria for identifying P and vP substances established by reference to the persistency of a substance in soil.

131 Second, the interpretation advocated by the applicants, as the Commission rightly points out, does not take into account transfers of substances between compartments, such that a substance which is persistent in one compartment, sediment for example, may be transferred to another compartment, for example sea water, where it may bioaccumulate or have toxic effects.

132 Third, according to the second paragraph of the preamble to Annex XIII, the weight-of-evidence determination using expert judgement compares ‘all relevant and available information listed in Section 3.2 [of that annex] with the criteria set out in Section 1’. It is clear that this refers in particular to information based on data which are obtained from different compartments or which concern animals living in different compartments (for example, aquatic and terrestrial species and birds). Similarly, Section 3 of Annex XIII refers to factors which in themselves may fall within several compartments, such as the BMF, by reference to which the Commission emphasises that predators and prey can live in different compartments or in multiple compartments.

133 It follows that the applicants’ argument that PBT and vPvB properties were identified in different compartments must be rejected.

(5) The alleged failure to take into account all relevant and available information

134 The applicants claim that the opinion of the MSC did not consider certain studies (such as the Bridges and Solomon studies, the Gobas study and the information provided on it, the Ruus study, the Sanchis study, the Hong et al. study, the Jia et al. study and the Krogseth et al. study). They assert that considering them would have materially affected the weight-of-evidence determination and the conclusion. The applicants add that, contrary to what is provided in the second and third paragraphs of the preamble to Annex XIII, the data were not considered and assessed together.

135 In that context, they assert that the RAC did not reassess P, vP, B and vB properties as part of its opinion of 10 March 2016, and that the data which were examined by the RAC were examined separately and in isolation from the full weight of the evidence.

136 The Commission disputes those arguments.

137 As a preliminary point, it should be noted that the applicants’ argument that the information was not taken into account together is linked to their plea alleging breach of essential procedural requirements and, in particular, to the argument that the RAC evaluated the T properties of the two substances, without re-evaluating their vP and vB properties. In that regard, reference is therefore made to the assessment of that plea.

138 Next, it must be stated that it is apparent from the file that the majority of the studies listed by the applicants – or their draft versions – were either taken into account during the evaluation process or were not yet available at the time of the evaluation of the PBT properties of the substances at issue by the MSC, which issued its opinion on 22 April 2015, as the Commission rightly points out.

139 First, the United Kingdom, in documents entitled ‘Comments 2nd round of call for evidence’ relating to D4 and D5 respectively, responded to the draft versions of the Bridges and Solomon studies (comment No 67) and to the Gobas articles submitted in the public call for evidence issued in the context of the opinion of the MSC (comment No 71). Annexes 2 and 3 to the opinion of the MSC contain references to the Hong et al. and Jia et al. studies and indicate a conclusion of them while noting that they have not been evaluated. As regards the Jia et al. study in particular, a summary of it was taken into account in order to highlight the difficulty in determining the current level of trophic magnification. It is found that that study indicates a probability of 94.7% or of 99.8% of observing a TMF value of higher than 1 for D4 and D5, respectively. The Sanchis (2015) study was mentioned and summarised by the RAC in the reference document accompanying its opinion. Second, the Krogseth et al. (2017) and Ruus (2017) studies were not submitted during the public call for evidence and were not available until 2017 and therefore could not be taken into account either by the MSC in 2015 or by the RAC in 2016.

140 As is apparent from the applicants’ observations to a question from the Court, the applicants do not dispute that finding, but criticise the fact that the assessment of the Bridges and Solomon studies and the Gobas articles is to be found not in the opinion of the MSC, but in a document prepared by the United Kingdom, and that the references in the annexes to that opinion to the Hong et al. and the Jia et al. studies indicate that those studies were not evaluated. Thus, according to the applicants, that information was not considered ‘in the MSC’s so-called weight-of-evidence determination’.

141 That argument must be rejected since there is no provision of Annex XIII requiring that the evaluation of all available information be described in detail in one specific document. In the context of a lengthy administrative procedure such as the one that preceded the adoption of the contested regulation and in the face of a considerable amount of information to be evaluated as in the case at hand, it may be appropriate, inter alia, to describe the evaluation of the information in various documents and annexes and in a summary manner, in particular according to the relevance and importance of that information. In that regard, it should also be noted that the second paragraph of the preamble to Annex XIII applies only to ‘relevant … information’ and that the third paragraph of that preamble applies only to ‘available information bearing on the identification of a PBT or a vPvB substance’. There is inter alia no obligation for the MSC to describe the evaluation of the information which has been considered not to be relevant and not having such a bearing, or even for it to list it in its opinion exhaustively.

142 In any event, it should be pointed out that the applicants, in the application, merely assert that the studies which, according to them, were not considered would have ‘materially affected the weight-of-evidence determination and [the] conclusion’. The applicants do not specify how such consideration could have had a bearing on the conclusion that D4 and D5 have vB properties. Nor do the applicants make any distinction between the two substances or, in particular, indicate what impact each study could have had on the evaluation and on the conclusion relating to the vB properties of D4, on the one hand, and of D5, on the other hand.

143 It is only at the stage of their observations on the Commission’s replies to the questions from the Court and only as regards certain publications prior to the Ruus study on the monitoring of siloxanes in the Oslo fjord between 2014 and 2017 that the applicants indicated how, in their view, the taking into account of those specific publications could have had an impact on the evaluation of the PBT and vPvB properties of D4 and D5. The applicants specified in those observations that certain of those publications indicate a biodilution of D4 and D5.

144 In that regard, it is appropriate to recall that the MSC noted variable results concerning the field data on biomagnification and the TMF and that certain studies on trophic magnification supported the conclusion on the bioaccumulation of D4 and D5. The MSC also found that the information on the BMF and the TMF available on the ground, which indicated that biodilution had occurred in some food chains, did not invalidate the other lines of evidence. The MSC took into account the ECHA Guidance according to which the absence of biomagnification cannot be used to disregard a valid assessment based on reliable BCF data indicating that a substance meets the criteria for B and vB substances set out in Annex XIII. Therefore, even if one or more additional studies had indicated biodilution in certain other food chains, that would not have changed either the overall assessment described by the MSC, according to which there were variable results in that regard, or its conclusion that the information indicating that biodilution had occurred in some food chains did not invalidate the other lines of evidence, in particular those relating to bioconcentration.

145 As regards the other studies referred to by the applicants, it should be noted that the Jia et al. study, for example, even indicates, according to what is stated in the annexes to the opinion of the MSC, a high probability of trophic magnification. The applicants do not state how the references to that study are erroneous or irrelevant. Likewise, the applicants do not indicate how the references to the Hong et al. study contained in the annexes to the opinion of the MSC, the reference to the Sanchis study appearing in the annex to the opinion of the RAC and the United Kingdom’s replies to the draft versions of the Bridges and Solomon studies and to the Gobas articles are erroneous or irrelevant.

146 Accordingly, their line of argument according to which certain relevant studies were not duly taken into consideration must be rejected.

(6) The importance placed on the data

147 The applicants, supported by ACC, argue that the application of a weight-of-evidence determination using expert judgement in the present case was not ‘credible’, because no quantitative weight was apportioned to each piece or body of evidence. ACC submits that the failure by the MSC to assign quantitative weights to the available information goes against the ECHA Guidance. A weight-of-evidence determination involves the assessment of the relative weights or values of the available information. It is not sufficient to review a large number of studies. The applicants add that a quantitative approach is necessary for reasons of transparency and in order to prevent arbitrary decisions.

148 It must be pointed out that Annex XIII does not require, in the context of a weight-of-evidence determination, that each item of evidence be given a quantitative value, as the Commission, supported by the Federal Republic of Germany, the United Kingdom and ECHA, rightly contends.

149 It is apparent from the preamble to Annex XIII that ‘appropriate weight’ is to be given to the quality and consistency of the data, that the available results are to be assembled together in a single weight-of-evidence determination and that it is necessary to compare the information listed in Section 3.2.2 with the criteria mentioned in Sections 1.1.2 and 1.2.2 of that annex. In order for ‘appropriate weight’ to be given to the quality and consistency of the data, it is not essential that an exact numerical value be given to each item of evidence. It follows from the use of the words ‘by comparing’ that the information listed in Section 3.2.2 must be examined in the light of its similarities with and differences from the criteria. That does not necessarily imply a purely quantitative approach. Thus, the rules set out in Annex XIII allow the competent EU authorities to apply a quantitative or qualitative weight-of-evidence determination. The choice of the competent authorities between those options in a given case depends on the circumstances of the case, in particular on the nature of the available information to be compared.

150 The ECHA Guidance encourages a quantitative approach for either all or part of the available information. ECHA also states in that document that the establishment of a conclusion property by property requires expert judgement, especially where different types of information are available and cannot be compared directly – that is to say, numerically – with the criteria.

151 Consequently, the description of that approach in the ECHA Guidance and the application of the weight-of-evidence determination without giving a precise value to each item of evidence in the case at hand are consistent with the provisions of Annex XIII, such that the applicants’ line of argument in that respect must be rejected.

(7) Certain other errors allegedly committed during the hazard assessment and in the identification of D4 and D5 as PBT and vPvB or vPvB substances pursuant to Annex XIII

152 It is necessary to reject as out of time and therefore inadmissible, under Article 84(1) of the Rules of Procedure, the applicants’ line of argument, raised for the first time in their observations on the statements in intervention of ECHA and ACC, according to which ECHA misinterpreted certain data relating to the BMF in finding that they demonstrated the existence of bioconcentration after having misapplied a lipid correction and a growth-dilution correction. According to the applicants, other data related to the BMF were interpreted as indicating the existence of bioaccumulation. According to the applicants, those data demonstrate, in reality, the opposite, namely the existence of biodilution. The Court must also reject as out of time the arguments set out in the applicants’ observations on the Commission’s replies to the questions from the Court, according to which BCF values were also poorly corrected for growth.

153 Those arguments, after all, do not constitute an amplification of a complaint made in the application and the applicants have neither alleged nor demonstrated that they are based on matters of law or of fact which came to light in the course of the procedure.

154 In any event, as the Commission and ECHA indicate in their replies to the questions put by the Court, the correction at issue was applied in accordance with OECD Guideline No 305 and Section C.13 of the annex to Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods in accordance with Regulation No 1907/2006 (OJ 2008 L 142, p. 1). The applicants have not demonstrated that errors were made in applying that correction, but rather merely criticise the fact that a correction was applied. The application of the methodology recognised by the OECD and provided for in Regulation No 440/2008, however, cannot be regarded, in itself, as manifestly erroneous on the basis of the applicants’ general statement in the reply.

155 Similarly, the applicants’ assertion of a misinterpretation of a BMF value of 0.31 as indicating the existence of bioaccumulation must, in any event, be rejected as factually incorrect. As ECHA and the Commission contend in their replies to the questions put by the Court and as is apparent from the file, in particular from the opinion of the MSC, the study by Inoue et al. (2012) was used only to support the conclusion according to which the BCF value of a substance could meet the criterion of vB substances even where its BMF value was lower than 1. Contrary to what the applicants claim, the MSC did not interpret the fact that a BMF value was lower than 1 as indicating the existence of bioaccumulation, but only as not contradicting a high BCF value. Consequently, the applicants’ claim stems from a misinterpretation of the opinion of the MSC. Moreover, that assessment by the MSC is consistent with what has been noted in regard to the relationship between bioconcentration and biomagnification in paragraph 95 above.

156 Consequently and in the light of what has been found in paragraphs 74 and 75 above, the first part of the first plea, alleging a manifest error of assessment in the hazard assessment and in the identification of D4 and D5 as PBT and vPvB or vPvB substances pursuant to Annex XIII, must be rejected.

(b) Second part of the first plea: absence of unacceptable risk arising from the manufacture, use or placing on the market of D4 and D5 in wash-off cosmetic products

157 In the second part of the first plea, the applicants claim that the contested regulation does not comply with one of the conditions laid down for the adoption of a restriction defined in Article 68(1) of Regulation No 1907/2006, namely the condition that unacceptable risk must result from ‘the manufacture, use or placing on the market’ of a substance.

158 First, the contested regulation does not aim to address a purported concern which arises from the manufacture, use or placing on the market of a substance, but relates to waste. The applicants refer to Article 2(2) of Regulation No 1907/2006, as well as to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ 2000 L 327, p. 1) and to Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ 2008 L 312, p. 3).

159 Second, the contested regulation covers an alleged risk arising from the disposal of wash-off cosmetic products and not from the manufacture, use or placing on the market of such products. Nor does the contested regulation restrict the use of products, contrary to what was originally proposed. In omitting a restriction on use in favour of a prohibition on placement on the market, that regulation fails to comply with the requirements arising under Section II 3 of Annex XV, according to which a restriction ‘must be targeted to the effects or exposures that cause the risks identified’, even if it were true that the risks at issue arise from the use of the cosmetic products in question.

160 Third, the applicants maintain that wash-off cosmetic products containing D4 and D5 can be used with water in a manner which does not pose any risk.

161 The Commission disputes those arguments.

162 In that regard, it should be recalled that Article 68(1) of Regulation No 1907/2006 provides for the adoption of new restrictions for the manufacture, use or placing on the market of substances when there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Union-wide basis.

163 As regards the applicants’ first argument, it should first of all be stated that, according to Article 1(2) of Regulation No 1907/2006, Regulation No 1907/2006 lays down provisions on substances and mixtures within the meaning of Article 3 of that regulation, applicable to the manufacture, placing on the market or use of such substances on their own, in mixtures or in articles and to the placing on the market of mixtures. According to the definition set out in Article 3(1) of that regulation, a substance is a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. It is undisputed that D4 and D5 are substances within the meaning of that definition.

164 It is admittedly true that, according to Article 2(2) of Regulation No 1907/2006, waste as defined in Directive 2008/98 is not a substance within the meaning of Article 3 of that regulation. Thus, a substance can cease to be a substance for the purposes of Article 3 of Regulation No 1907/2006 when it becomes waste as defined in EU law (see, to that effect, judgment of 10 September 2015, FCD and FMB, C‑106/14, EU:C:2015:576, paragraph 52).

165 However, it must be stated that the fact that a substance can lose its status as a substance at the end of its lifecycle for the purposes of Article 3 of Regulation No 1907/2006 is not such as to call into question its status as a substance before that event. That is not apparent either from the definition of the term ‘substance’ contained in Article 3(1) or from Article 2(2) of that regulation.

166 The contested regulation concerns the placing on the market of D4 and D5 in certain products and not the management of waste containing D4 and D5. It should be stated that, at the stage of their being placed on the market, D4 and D5 constitute substances under Article 3(1) of Regulation No 1907/2006.

167 Accordingly, the applicants’ line of argument according to which the contested regulation relates to waste must be rejected.

168 As regards the applicants’ second argument concerning the target of the contested regulation, it must be stated that the placing on the market of D4 and D5 is the origin of their use, which gives rise to the risk at issue. There is nothing in the wording of Article 68(1) of Regulation No 1907/2006 to indicate that the restriction should apply exclusively to the point in the lifecycle of the substance in question at which the risk concerned by the restriction immediately and directly materialises.

169 In that regard, it should be noted, as the Commission rightly contends, that risks rarely arise from the placing on the market – in the strict sense of the term and including, in accordance with Article 3(12) of Regulation No 1907/2006, import – of substances, mixtures or articles. Their intended subsequent use and their lifecycle should be considered.

170 A restriction on the placing on the market – including, in accordance with the definition in Article 3(12) of Regulation No 1907/2006, import – of a substance is often the most effective measure for achieving the objective pursued by that regulation, which is to ensure a high level of protection of human health and the environment. If a substance is not placed on the market, it may not be used. On the contrary, hypothetical restrictions prohibiting the use of such products by consumers and final users who are professionals without restricting their being placed on the market would not always enable the risk to be managed effectively.

171 Thus, an interpretation whereby a restriction could apply only at the final stage following which the risks materialise would considerably weaken the effectiveness of the restriction tool provided for in Article 68 of Regulation No 1907/2006 in order to ensure a high level of protection of human health and the environment.

172 It must consequently be held that the contested regulation concerns, in accordance with Article 68(1) of Regulation No 1907/2006, the placing on the market of D4 and D5 in wash-off cosmetic products.

173 Accordingly, and subject to the examination of the other arguments of the applicants concerning the alleged alternatives to the restriction adopted by the contested regulation, in the context of the second plea, the second part of the first plea must also be rejected.

(c) Third part of the first plea: errors allegedly committed in the risk assessment

174 In the third part of the first plea, the applicants, supported by ACC, claim that the risk assessment in this case is vitiated by manifest errors in the assessment of the facts and by errors in law and that it contains an inadequate statement of reasons.

175 They maintain that the United Kingdom, which submitted the Annex XV dossier proposing the restriction at issue, made a manifest error of assessment in considering that any emissions of D4 and D5 were a proxy for ‘unacceptable risk’. According to that interpretation, which ECHA and the Commission subsequently adopted, any emissions of D4 and D5 automatically constitute an ‘unacceptable risk’. Consequently, only zero emissions would have been judged acceptable. That is impossible to achieve in practice. Moreover, again according to that interpretation, the hazard properties alone of a substance constitute an unacceptable risk, which is not consistent with the legislature’s intention.

176 The need to quantify the risks arises also under Section II 3 of Annex XV, according to which, to justify a restriction at Union level, it is necessary to establish that that restriction is capable ‘of reducing these risks to an acceptable level within a reasonable period of time’ and that it is ‘proportional to the risk’. Section 6.5 of Annex I should not be interpreted to mean that it is not possible to control the risks of PBT and vPvB substances and that, consequently, all potential and actual emissions must be minimised regardless of whether the emissions and adverse effects are sufficiently controlled. The applicants, supported by ACC, assert that such a hypothetical approach seeking to reduce the risk to zero is not in accordance with EU law.

177 The applicants also assert that a threshold level of emissions or exposure applies, below which there is no ‘relevant effect or … adverse effect’. Emissions below that threshold do not constitute a risk or an unacceptable risk within the meaning of Article 68(1) of Regulation No 1907/2006. It follows from that provision that only an ‘unacceptable risk’ justifies the adoption of a restriction, which indicates that there is a tolerance of exposure.

178 In addition, the applicants, supported by ACC, argue, relying on the judgment of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209, paragraph 151), that it was necessary to establish a ‘critical probability threshold for adverse effects on human health [and the environment] and for the seriousness of those possible effects – which … is [judged as] no longer acceptable for society [and/or the environment] and above which it is necessary, in the interests of protecting human health [and the environment], to take preventive measures’. However, in the case at hand, no critical probability threshold was established.

179 Moreover, in this case, there are no ‘relevant adverse effects’. Persistency and bioaccumulation per se, taken in isolation or together, do not constitute ‘adverse effects’ on human health or the environment. The applicants maintain in the reply, referring to certain studies annexed to it, that, due to those physicochemical properties, the reversibility of D4 and D5 is shorter than that of PBT and vPvB substances.

180 The applicants dispute that Annexes I and XV set out the risk assessment to be undertaken in the context of the adoption of a restriction under Title VIII of Regulation No 1907/2006.

181 With regard, first, to Annex I, it sets out the general provisions for assessing substances and preparing safety reports and does not seek to limit the risk assessment under Title VIII of Regulation No 1907/2006. Moreover, ‘Section [II] 3 of Annex XV relates to information on “hazard and risk”’ and ‘Section 4.0.1 of Annex I REACH states that “a hazard assessment … cannot be carried out with sufficient reliability”’. According to the applicants, ‘Section 4.0.1 [of] Annex I therefore cannot be interpreted to preclude a valid risk assessment from being conducted in the context of the Title VIII REACH Restriction provisions’.

182 With regard, second, to Annex XV, it rather determines the general principles applicable to the proposal and initial justification of a restriction but should not limit the RAC’s risk assessment in accordance with Article 70 of Regulation No 1907/2006. This follows from that provision, according to which the RAC itself is to formulate its opinion ‘as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment’ and according to which it must form its opinion ‘based on its consideration of the relevant parts of the dossier’. In this case, the RAC failed to respect its obligations by limiting itself to the issues set out in the Annex XV dossier and by not assessing the risk, as it believed that it was not possible to assess the risk and exposure.

183 The applicants assert that the outcome would have been different had a risk assessment been done, first, because it is apparent from an assessment of the hazards relating to D4 and D5 and exposure to those substances that the risks are negligible owing to their unique properties, second, due to that incorrect use of any emission as a proxy for risk, third, because that presumption prevented the Commission and ECHA from considering the proportionality of the contested regulation and, fourth, because the Commission and ECHA did not assess the varying degrees of risk relating to the variety of products covered by the contested regulation.

184 The Commission, supported by the Federal Republic of Germany and the United Kingdom, disputes those arguments.

185 As a preliminary point, it is appropriate to clarify the scope of the judgment of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209), in which the Court ruled on the interpretation of the Commission’s communication on the precautionary principle of 2 February 2000. The Court held in that judgment that that communication could be taken as a codification of the law as it stood at the time when the regulation at issue in the case giving rise to that judgment was adopted (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 149).

186 However, it must be pointed out that the contested regulation in the present case was adopted on the basis of Article 68(1) of Regulation No 1907/2006 and had to comply with the conditions that were set out therein.

187 Consequently, and in accordance with Article 70 and Article 68(1) of Regulation No 1907/2006, the adoption of the contested regulation presupposed that the Commission was right to take the view that the placing on the market of D4 and D5 in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance involved an unacceptable risk to human health or the environment which needed to be addressed on a Union-wide basis.

188 In the light of the line of argument put forward by the applicants in relation to the alleged absence of a risk assessment, it must be stated that it is based on a misinterpretation of Annexes XV and I and on a failure to take into account the specific features of the assessment of the risks associated with PBT and vPvB substances.

189 According to Section II 3 of Annex XV, under the heading ‘Information on hazard and risk’, the risks to be addressed with the restriction are to be described ‘based on an assessment of the hazard and risks according to the relevant parts of Annex I’.

190 Annex I lays down a number of specific provisions applicable to PBT and vPvB substances which are an embodiment of the precautionary principle, as the Commission and the Federal Republic of Germany rightly submit. It is apparent in particular from the provisions of Annex I that the standard approach for the risk assessment described in Section 6.4 of that annex, according to which an environmental risk can be considered to be adequately controlled if the estimated exposure levels do not exceed the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur (Predicted No-Effect Concentrations; ‘PNECs’), does not apply to PBT and vPvB substances. According to Section 4.0.1 of Annex I, neither a hazard assessment addressing all the long-term effects, including the establishment of PNECs according to Section 3 of that annex, nor the estimation of the long-term exposure of the environment is sufficiently reliable for PBT and vPvB substances. Section 6.5 of Annex I provides that a ‘qualitative assessment of the likelihood that effects are avoided’ for substances, such as PBT and vPvB substances, for which it is not possible to establish PNECs, is to be carried out. Moreover, the same section mentions the aim of minimising exposures to PBT and vPvB substances and emissions to humans and the environment.

191 It is apparent from those provisions that it is not possible to address with sufficient reliability and in a quantitative manner the risks associated with PBT and vPvB substances. That finding is also confirmed by the fact that, according to Article 60(3)(b) of Regulation No 1907/2006, the granting of an authorisation on the ground that the risk to the environment is adequately controlled is not possible for PBT and vPvB substances. Such an authorisation may be granted under Article 60(4) of Regulation No 1907/2006 only if it is shown that the socio-economic benefits outweigh the risks and if there are no suitable alternative substances or technologies.

192 Contrary to what the applicants claim, those principles established in Annex I apply not only to the Annex XV dossier, but also in the context of the subsequent steps of the process of adopting a restriction. First, the argument that the legislature laid down principles applicable to the risk assessment for one step of the process leading to the adoption of a restriction, namely for the prop