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

JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

16 December 2020 (*)

(REACH – Substance evaluation – UVASORB HEB – Decision of the ECHA requesting further information – Article 46(1) of Regulation (EC) No 1907/2006 – Request seeking to identify potential transformation or degradation products of the substance – Proportionality – Need for the additional study requested – Relevant conditions and realistic conditions – Study temperature – Manifest error of assessment)

In Case T‑176/19,

3V Sigma SpA, established in Milan (Italy), represented by C. Bryant and S. Hainsworth, Solicitors, and by D. Anderson, lawyer,

applicant,

v

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

defendant,

supported by

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

intervener,

ACTION under Article 263 TFEU seeking the annulment in part of Decision A-004-2017 of the ECHA Board of Appeal of 15 January 2019 in so far as it dismissed the applicant’s appeal against the decision of the ECHA of 20 December 2016 requiring that further information be provided about the substance UVASORB HEB and in so far as the deadline for providing that information was set at 22 October 2020,

THE GENERAL COURT (Seventh Chamber),

composed of R. da Silva Passos, President, I. Reine (Rapporteur) and M. Sampol Pucurull, Judges,

Registrar: E. Coulon,

gives the following

Judgment

I.      Background to the dispute and the contested decision

1        The applicant, 3V Sigma SpA, is a producer of chemical products. It is the lead registrant of the substance bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate, with the number CAS 154702-15-5 (‘UVASORB HEB’). That substance is used as an ultra-violet light filter in cosmetic products.

2        In 2015, UVASORB HEB was included in the rolling action plan for substance evaluation as provided for in Articles 44 to 48 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1; corrigendum OJ 2007 L 136, p. 3), on account of initial grounds for concern relating to its potential persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties.

3        Pursuant to Article 45 of Regulation No 1907/2006, the competent authority of the Federal Republic of Germany (‘the competent authority’) was appointed to carry out the evaluation of UVASORB HEB.

4        On 26 April 2016 the competent authority provided the applicant with a draft decision within the meaning of Article 46(1) of Regulation No 1907/2006 seeking additional information from the applicant for the purposes of the competent authority’s evaluation. Specifically, that draft decision required the applicant to provide the results of a study conducted in accordance with the Organisation for Economic Co-operation and Development (OECD) 309 guidelines for the testing of chemicals, together with further information on the uses of UVASORB HEB and environmental emissions. The applicant submitted its comments on that draft decision on 2 June 2016.

5        On 21 July 2016 the competent authority communicated the draft decision, together with the applicant’s comments, to the competent authorities of the other Member States and to the ECHA, in accordance with Article 52(1) of Regulation No 1907/2006.

6        Following comments received on the draft decision and taking account of the applicant’s observations on those comments, the competent authority amended the draft decision by replacing the requirement to conduct the study in accordance with the OECD 309 guidelines with a requirement to conduct a study in accordance with the OECD 308 guidelines for the testing of chemicals (‘the OECD 308 guidelines’). It then communicated the draft decision, as amended, to the Member State Committee in accordance with Article 51(4) of Regulation No 1907/2006.

7        On 10 October 2016 the Member State Committee unanimously endorsed the amended draft decision, as provided by the competent authority.

8        On 20 December 2016, the ECHA adopted a decision on substance evaluation concerning UVASORB HEB (‘the initial decision’), by which, under Article 46(1) of Regulation No 1907/2006, registrants, including the applicant, were required to provide:

–        first, the results of sediment simulation testing (aerobic and anaerobic transformation in aquatic sediment systems, EU C.24/OECD 308) using the substance (UVASORB HEB) at 20 °C according to the specification of the test conditions listed in section 1.1.3 of Appendix 1 to that decision (‘the OECD TG 308 study’);

–        second, further information on uses and environmental emissions, as specified in Appendix 1 to that decision.

9        It is also clear from section 1.1.3 of Appendix 1 to the initial decision that the OECD TG 308 study was to comply with certain requirements, set out as follows:

‘The requested simulation study on degradation of UVASORB HEB in sediment should enable i) the determination of degradation pathways of UVASORB HEB in sediment with regard to the formation of metabolites and ii) the identification of formed metabolites of UVASORB HEB. The OECD 308 simulation test should be performed using I4C-radiolabelled UVASORB HEB. The radiolabel should be located in [the] most stable part of the molecule, thus the 1,3,5-triazine ring. Radiolabelling of the most stable part of the molecule is necessary for identification of transformation products relevant for PBT assessment (at a concentration of ≥ 0.1% w/w unless it can bе demonstrated that this is technically not possible).

…

According to the test on ready biodegradation, UVASORB HEB degrades slowly. To maximise the probability for the formation and identification of metabolites of UVASORB HEB in the requested [OECD TG 308 study], a temperature of 20 °C has been selected.’

10      On 20 March 2017 the applicant lodged an appeal before the ECHA Board of Appeal against the initial decision on the basis of Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and of Article 91(1) thereof.

11      In accordance with Article 91(2) of Regulation No 1907/2006, the appeal brought before the ECHA Board of Appeal against the initial decision had suspensive effect.

12      On 15 January 2019 the ECHA Board of Appeal adopted Decision A-004-2017 on the evaluation of the chemical substance UVASORB HEB (‘the contested decision’). By that decision, it annulled in part the initial decision in so far as it requested additional information on uses and environmental emissions. It dismissed the appeal as to the remainder. In addition, the contested decision set a deadline of 22 October 2020 for providing the results of the OECD TG 308 study.

13      As regards, more particularly, the need for the OECD TG 308 study, the ECHA Board of Appeal rejected each of the complaints raised by the applicant. First, it considered that the request to carry out that study was not disproportionate, having regard to, in essence, the potential risks of the substance’s transformation and degradation products, the need to clarify those risks, the possibility of improving risk management measures and the fact that it was appropriate to carry out the requested study using a temperature of 20 °C. Secondly, it took the view that the ECHA had carefully and impartially examined all the relevant arguments and facts of the case, including all the studies and predictions based on the quantitative structure-activity relationship models (‘the QSAR models’) submitted by the applicant regarding UVASORB HEB’s PBT properties, so that it had not made any manifest error of assessment in calling for the study in question. Third, it confirmed that, as had been acknowledged by the ECHA, the initial decision had to be read as meaning that the threshold for identifying transformation and degradation products was a concentration equal to or higher than 10% (and not 0.1% as stated in that decision).

II.    Procedure and forms of order sought

14      By application lodged at the Court Registry on 25 March 2019, the applicant brought the present action.

15      By a separate document lodged at the Court Registry on 29 March 2019, the applicant lodged an application for interim relief seeking, in particular, suspension of the operation of the contested decision.

16      The ECHA lodged its defence at the Court Registry on 13 June 2019.

17      By a document lodged at the Court Registry on 21 June 2019, the Federal Republic of Germany applied for leave to intervene in support of the form of order sought by the ECHA.

18      By order of 15 July 2019, 3V Sigma v ECHA (T‑176/19 R, not published, EU:T:2019:547), the President of the General Court dismissed the applicant’s application for interim relief on the ground that it had failed to establish urgency. The costs relating to those proceedings were reserved.

19      By decision of 31 July 2019, the President of the Fourth Chamber of the General Court granted the Federal Republic of Germany leave to intervene in support of the form of order sought by the ECHA.

20      The applicant lodged its reply at the Court Registry on 21 August 2019.

21      The ECHA lodged its rejoinder at the Court Registry on 4 October 2019.

22      The Federal Republic of Germany lodged its statement in intervention on 11 October 2019.

23      Following a change in the composition of the Chambers of the General Court, pursuant to Article 27(5) of its Rules of Procedure, the Judge Rapporteur was assigned to the Seventh Chamber, to which the present case was accordingly allocated.

24      The applicant and the ECHA lodged their comments on the statement in intervention on 25 November 2019 and 21 November 2019 respectively.

25      The applicant claims that the Court should:

–        annul the contested decision in so far as it dismissed the applicant’s appeal against the initial decision and decided that the applicant was required to provide the information relating to the OECD TG 308 study by 22 October 2020 at the latest;

–        order the ECHA to pay the costs incurred by the applicant.

26      The ECHA contends that the Court should:

–        dismiss the action for annulment;

–        order the applicant to pay the costs of ‘both parties’.

27      The Federal Republic of Germany contends that the Court should dismiss the action.

III. Law

A.      Admissibility of the defence

28      In the reply, the applicant expresses doubts regarding whether the ECHA’s defence was lodged within the time limit. It states that the Court, in its letter dated 28 March 2019, had informed the applicant of the fact that the application had been served on the ECHA. However, the defence was not lodged until 13 June 2019, that is, more than two months and ten days after that letter.

29      The ECHA’s response is that it did not accept service of the application in the e-Curia system until 3 April 2019, so that the defence was actually lodged within the time limit.

30      In the present case, the third paragraph of Article 6 of the Decision of the General Court of 11 July 2018 on the lodging and service of procedural documents by means of e-Curia (OJ 2018 L 240, p. 72) provides that a procedural document is served at the time when the intended recipient (representative or assistant) requests access to that document. In the present case, therefore, the time limit for lodging the defence started to run from the time when the ECHA requested access to the Court’s letter and to the application and its annexes in the e-Curia system.

31      It is apparent from the e-Curia report that the Court’s letter as well as the application and its accompanying annexes were accepted by the ECHA on 3 April 2019. Accordingly, the two-month time limit for lodging the defence, extended on account of distance by a single period of 10 days laid down in Article 60 of the Rules of Procedure, expired on 13 June 2019, which is the date on which the defence was in fact lodged. Therefore, the ECHA cannot be accused of having submitted that document out of time.

B.      Substance

32      In support of the action, the applicant raises two pleas, claiming, first, an error of law and a manifest error of assessment as regards the need to carry out the OECD TG 308 study and, second, an error of law and a manifest error of assessment as regards whether the temperature and test conditions imposed for that study were appropriate.

1.      The first plea in law, claiming an error of law and a manifest error of assessment as regards the need to carry out the OECD TG 308 study

33      The applicant disputes the ECHA Board of Appeal’s assessment in the contested decision of the need to carry out the OECD TG 308 study. Its line of argument is based, in essence, on the fact that there are no known transformation or degradation products of UVASORB HEB, any PBT or vPvB properties of which should be taken into account. The results of the study carried out in accordance with the OECD 301B guidelines for the testing of chemicals, placed in the file by the applicant (‘the OECD RG 301B study’), in the applicant’s view, show in addition that UVASORB HEB does not biodegrade easily and that it is unlikely that such products would be formed in practice, under realistic conditions.

34      According to the applicant, in the light of the fourth introductory paragraph of Annex XIII to Regulation No 1907/2006, a distinction must be drawn between, on the one hand, the ‘realistic’ conditions under which it is necessary to identify a substance’s potential transformation or degradation products, and, on the other hand, the ‘relevant’ conditions under which it is necessary to evaluate the properties of those products. It claims that such products are of concern, for the purposes of that regulation, only if they would actually exist in the environment and not solely under artificial conditions, as is apparent, in particular, from Version 3.0 of Chapter R.11 of the ECHA’s Guidance on Information Requirements and Chemical Safety Assessment of June 2017 (‘the ECHA Guidance’).

35      In those circumstances, the applicant takes the view that the ECHA Board of Appeal could not rely solely on the results of the QSAR models, which show only possible degradation pathways for UVASORB HEB, in order to reach the conclusion that the formation of a number of potential transformation or degradation products could be expected.

36      For those reasons, and given the low level of uncertainty regarding whether transformation or degradation products of UVASORB HEB are likely to be formed, the applicant’s view is that the ECHA Board of Appeal should have concluded that the OECD TG 308 study was disproportionate. It argues that in deciding to confirm the initial decision that that test was necessary, the Board of Appeal, accordingly, erred in law and made a manifest error of assessment.

37      The ECHA and the Federal Republic of Germany contest the applicant’s arguments.

(a)    Preliminary observations

38      As is apparent from settled case-law, the principle of proportionality, which is one of the general principles of EU law, requires that measures implemented through EU provisions should be appropriate for attaining the objective pursued and must not go beyond what is necessary to achieve it (see judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 41 and the case-law cited).

39      As regards the review by the Court of the conditions referred to in paragraph 38 above, it must be recalled that where the European Union 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, 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 (see, to that effect, judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited).

40      In order to establish that an EU institution or body has made a manifest error in assessing complex facts such as to justify the annulment of an act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted that decision (see judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 86 and the case-law cited).

41      The first plea raised by the applicant must be examined in the light of those principles.

(b)    Whether it was necessary to identify the possible formation of transformation or degradation products of UVASORB HEB

42      As can be seen from the initial decision, of which the draft public version provided as an annex to the application is implicitly regarded by the parties as reflecting the definitive version of that decision, the applicant was requested to carry out the OECD TG 308 study in order to clarify areas of uncertainty regarding the possible formation of metabolites of UVASORB HEB. More particularly, the request for additional information was based on the following considerations:

–        first, the results of the OECD RG 301B study submitted by the applicant show 6% degradation of UVASORB HEB after 28 days of incubation, as well as the formation of carbon dioxide in water;

–        second, UVASORB HEB is a large molecule with complex degradation pathways – in that regard, the only estimates or predictions available, namely those based on the QSAR models, clearly show that a number of UVASORB HEB metabolites are capable of being formed and displaying PBT or vPvB properties.

43      In the contested decision, the ECHA Board of Appeal confirmed that the purpose of the request for additional information in the present case was to clarify uncertainty over whether transformation or degradation products of UVASORB HEB were likely to be formed and, if so, which ones. In that regard, it emphasised that, under the fourth introductory paragraph of Annex XIII to Regulation No 1907/2006, the assessment of substances must be based on data obtained under ‘relevant’ conditions, that is to say conditions which enable an objective assessment of the properties of a substance, instead of particular environmental or ‘realistic’ conditions. It added that the predictions from the QSAR models provided by the applicant itself indicate that UVASORB HEB may form transformation or degradation products in the environment.

44      In the present case, it must be recalled that, in order to demonstrate that a request for further information is necessary, it is for the ECHA to establish that the substance at issue poses a potential risk for human health and the environment, that it is necessary to clarify that risk and that there is a realistic possibility that the information requested allows improved risk management measures to be taken (judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 276).

45      As a preliminary point, it must be observed that, in its arguments, the applicant does not maintain that the ECHA Board of Appeal made a manifest error of assessment in taking the view that there was a realistic possibility that the information requested allowed improved risk management measures to be taken.

46      As regards whether there was a potential risk that needed to be clarified, it is common ground that UVASORB HEB is not regarded, as a parent substance, as a PBT or vPvB substance within the meaning of Annex XIII to Regulation No 1907/2006. Nevertheless, as can be seen from the fifth introductory paragraph of that annex, that factor alone is not sufficient to preclude any substance from being categorised as a PBT or vPvB substance. Indeed, account must also be taken of the PBT or vPvB properties of the relevant constituents and transformation or degradation products of that substance.

47      As is apparent from the contested decision, the ECHA Board of Appeal relied on both the results of the OECD RG 301B study and the predictions from the QSAR models, both of which were provided by the applicant, in order to come to the conclusion that the formation of transformation or degradation products of UVASORB HEB, some of which might display PBT properties, could not be ruled out and that that uncertainty needed to be clarified. It is therefore necessary to determine whether, in relying on such results in order to justify the OECD TG 308 study, the Board of Appeal erred in law and made a manifest error of assessment, as is maintained by the applicant.

48      As regards, first, the results of the OECD RG 301B study, these demonstrated that UVASORB HEB is not readily biodegradeable. Accordingly, as the ECHA argues, the rapid and complete degradation of that substance in the environment is unlikely, which is not disputed by the applicant.

49      However, it is apparent from the version of the OECD 301 guidelines on chemical testing of 17 July 1992 enclosed by the ECHA as an annex to the defence, and in particular paragraph 2 of the section dealing with 301B tests (carbon dioxide evolution), that 301B tests carried out in accordance with those guidelines are tests of ready biodegradability, which seek to measure the degradability of a substance on the basis of the carbon dioxide given off by the substance concerned.

50      The ECHA and the Federal Republic of Germany maintain that the purpose of the 301B tests is thus to establish whether the substance analysed can undergo rapid and complete degradation in most environments, but that they are not designed to identify the substance’s degradation pathways, or its transformation or degradation products, with the exception of carbon dioxide. The applicant has in no way disputed that point and has not adduced any evidence capable of challenging it.

51      It is also apparent from page 51 of Chapter R.11 of the ECHA Guidance, cited on page 3 of the initial decision, that a negative result from the OECD RG 301B study does not necessarily mean that the substance will not be degraded under environmental conditions. One of the reasons for a lack of biodegradeability under such a test can be the low water solubility of the substance. As can be seen from the first paragraph of section 1.1.3 of Appendix 1 to the initial decision, this is a characteristic of UVASORB HEB.

52      In addition, even if it is apparent from the OECD RG 301B study that UVASORB HEB undergoes only weak degradation after 28 days, the fact remains that, taking account of the observed carbon dioxide values, such degradation of the substance has actually been established. In the present case, it increased to nearly 7% or 8% at the end of the period concerned, according to the concentration of the substance used, as is apparent from section 3.2 of that study, entitled ‘Biodegradeability’. The results of the study nevertheless provide no indication regarding the transformation or degradation products that might be formed; nor do they enable conclusions to be drawn regarding their absence, as the case may be.

53      Furthermore, it is not apparent either from the fifth introductory paragraph of Annex XIII to Regulation No 1907/2006 or from the other provisions of that annex that only the substances whose biodegradeability exceeds a certain threshold are concerned by the need to identify and take into account, where relevant, transformation or degradation products.

54      Moreover, even though rapid degradation of UVASORB HEB is unlikely, as demonstrated by the OECD RG 301B study conducted over a 28 day period, the ECHA stated in the initial decision that the substance degraded slowly, which the applicant expressly recognised in the application.

55      Therefore, the applicant cannot argue that the OECD RG 301B study removed all doubt as to the possibility of transformation or degradation products of UVASORB HEB being formed in the environment.

56      As regards, second, the consideration of the results of the QSAR models provided by the applicant in the context of its assessment of UVASORB HEB’s PBT or vPvB properties as set out in table 1 of the initial decision, it must be observed that in paragraph 28 of the application the applicant acknowledges that those results identified potential transformation or degradation products of the substance in question. In addition the applicant does not challenge the fact that those results were based on data obtained under ‘relevant’ conditions within the meaning of the fourth introductory paragraph of Annex XIII to Regulation No 1907/2006.

57      In addition, according to the system introduced by Regulation No 1907/2006, where there are concerns regarding potential risks for human health and the environment caused by a substance and it is not possible to dispense with them or to confirm them on the basis of available information, a decision relating to the evaluation of that substance may be adopted with a view to requesting further information allowing that risk to be clarified (judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 271).

58      Consequently, considering the areas of uncertainty created by the results of the QSAR models, and in the absence of clear data allowing the formation of transformation or degradation products of UVASORB HEB to be excluded, the ECHA Board of Appeal could, without making a manifest error of assessment or erring in law, take the view that it was necessary to request the applicant to clarify those areas of uncertainty and, consequently, to request additional information from it.

59      In view of the foregoing, the applicant’s arguments concerning the requirement to apply realistic conditions in order to identify transformation or degradation products of the substance in question are ineffective since they are not capable of calling into question either the areas of uncertainty that have been established or the need to clarify them. That being said, in so far as they are closely linked to arguments concerning the conditions under which the OECD TG 308 study is to be carried out in order to resolve the areas of uncertainty that have been established, their merits will be considered in the context of the second plea.

60      It should be added that, in section 1.1.3 of Appendix 1 to the initial decision, the ECHA stated that there was no appropriate alternative approach to obtaining the information sought which was less burdensome for the applicant. Nor has the applicant stated that such an alternative could be envisaged.

61      Consequently, the applicant’s first plea, claiming that the ECHA Board of Appeal erred in law and made a manifest error of assessment in concluding that the OECD TG 308 study was necessary, must be rejected as unfounded.

2.      The second plea in law, claiming an error of law and a manifest error of assessment as regards whether the temperature and test conditions imposed for the OECD TG 308 study were appropriate

62      The applicant claims that the OECD TG 308 study is not an appropriate means of achieving the objective pursued, given that the temperature at which that test is to be performed, namely 20 °C, is unrealistic. Such a temperature, far above the average temperature of European waters (12 °C), would lead to transformation or degradation products being formed in greater quantities and in higher concentrations than under real life conditions, so that the test would lead to erroneous results.

63      In that context, the applicant emphasises, first of all, that the assessment of the PBT or vPvB properties of transformation or degradation products must be conducted for each product identified at concentrations of 10% or above, so that restrictive measures could be imposed on account of PBT or vPvB properties of such products which, however, would never actually be formed. In the reply, it adds that a concentration of products below 10% must also be taken into account, where relevant, as can be seen from paragraph 41 of the OECD 308 guidelines.

64      Next, the applicant states that even if the temperature of 20 °C is within the range set out in the OECD 308 guidelines, that range is wide, so that it was for the ECHA Board of Appeal to select an appropriate temperature to identify the formation of transformation or degradation products.

65      Lastly, the applicant submits that the ECHA Board of Appeal did not demonstrate that a temperature of 20 °C was a realistic temperature for surface water in the European Union. In any event, the fact that such a temperature can in fact be reached at certain times of the year and in certain parts of the European Union is not sufficient to conclude that it is an appropriate temperature for performing the OECD TG 308 study. Rather, it is apparent from page 206 of Version 4.0 of Chapter R.7b of the ECHA Guidance of June 2017 and from page 59 of Chapter R.11 of that guidance that the mean temperature of surface water in the European Union is 12 °C.

66      The ECHA and the Federal Republic of Germany contest the applicant’s arguments. The ECHA takes the view, in particular, that the argument put forward by the applicant in the reply, based on paragraph 41 of the OECD 308 guidelines, was not raised before the Board of Appeal and is therefore not admissible.

67      In the present case, it is apparent from section 1.1.3 of Appendix 1 to the initial decision that, given UVASORB HEB’s slow degradation, it is appropriate to carry out the OECD TG 308 study at a temperature of 20 °C in order to maximise the probability of metabolites being formed and identified.

68      In paragraphs 90 to 93 of the contested decision, the ECHA Board of Appeal confirmed that a temperature of 20 °C was appropriate for performing the OECD TG 308 study for four reasons. First, the aim of the study is not to mimic real life conditions but to enable an objective assessment of the properties of UVASORB HEB. Second, the temperature of 20 °C is within the range of temperatures set out in paragraph 33 of the OECD 308 guidelines. Third, 20 °C is not an unrealistic temperature for surface water and sediment in certain parts of the European Union at certain times of the year. Fourth, in accordance with the purpose of the OECD TG 308 study, a temperature of 20 °C should accelerate the formation, where relevant, of transformation or degradation products, and thus make their identification easier. The Board of Appeal added that it was appropriate to retain the 10% concentration threshold for transformation or degradation products as set out in paragraph 41 of the OECD 308 guidelines.

69      It is necessary to examine each of the reasons relied on by the ECHA Board of Appeal in turn, by reference to the applicant’s arguments.

70      As regards, first, the question whether it is appropriate to carry out the OECD TG 308 study on the basis of ‘real life’ or ‘realistic’ conditions, rather than on the basis of ‘relevant’ conditions, enabling an objective assessment, it must be observed that the fourth introductory paragraph of Annex XIII to Regulation No 1907/2006 provides that information used for the purpose of assessing a substance’s properties must be based on data obtained under ‘relevant’ conditions. That paragraph, however, makes no distinction according to the nature of the information involved: in no way does it state that it is appropriate to rely on different conditions according to the information sought concerning the parent substance’s properties, identification of its transformation or degradation products, or the properties of those transformation or degradation products.

71      Nor is such a distinction apparent from the fifth introductory paragraph of Annex XIII to Regulation No 1907/2006. That paragraph states only that account should also be taken of the PBT and vPvB properties of the ‘relevant’ transformation or degradation products of substances in order to identify PBT or vPvB substances within the meaning of that annex, and provides no indication regarding the specific conditions under which the formation of such products should be determined. It cannot be inferred from the use of the term ‘relevant’ that the formation of those products must be examined in the light of different criteria from those set out in the fourth introductory paragraph of that annex, namely the ‘relevant’ criteria.

72      The wording of the fourth and fifth introductory paragraphs of Annex XIII to Regulation No 1907/2006 therefore does not permit the conclusion that the EU legislature intended to lay down ‘realistic’ conditions for the identification of transformation or degradation products and ‘relevant’ conditions for the consideration of their PBT or vPvB properties. On the contrary, the conditions must be ‘relevant’ in respect of each.

73      In addition, there is no general support in the text of Annex XIII to Regulation No 1907/2006 for the distinction put forward by the applicant. As the applicant itself acknowledges, no provision of that annex calls for the use of data obtained under ‘realistic’ rather than ‘relevant’ conditions in order to identify a substance’s transformation or degradation products, where these are not already known.

74      It must be added that the test methods to be applied for the purposes of Regulation No 1907/2006 are defined in the annex to Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 2008 L 142, p. 1). In particular, the conditions under which a test such as the OECD TG 308 study should be conducted are the subject of a detailed description in section C.24 of that annex. The applicant has in no way claimed that the test conditions required in the initial decision, and confirmed in the contested decision, do not comply with the conditions laid down in that annex.

75      The applicant does, however, claim that on page 51 of Chapter R.11 of the ECHA Guidance, under the heading ‘Tests on simulation of biodegradation’, it is stated that degradation simulations performed in appropriate environmental media and at environmentally realistic conditions are the only tests that can provide a definitive degradation half-life that can be compared directly to the persistence criteria as defined in Annex XIII to Regulation No 1907/2006. On page 52 of that chapter, it is clarified that the simulations described in the OECD TG 307, 308 and 309 studies address the fate and behaviour of a substance as it may be expected in the environment, including degradation pathways, and that the endpoints that need to be addressed concern, inter alia, degradation pathways and metabolites. According to the applicant, this clearly links the simulation of the degradation of substances and the production and identification of metabolites to realistic conditions.

76      In that regard, it must be observed that the applicant’s argument recalled in paragraph 75 above concerns tests seeking to obtain a substance’s degradation half-life. The ECHA has explained that where the purpose of a study is to determine the degradation rate of a substance, a test temperature of 12 °C is in fact more suitable. By contrast, where a study seeks to identify a substance’s transformation or degradation products, a higher test temperature, such as the 20 °C temperature in the present case, is more appropriate, since it results in a faster degradation rate and thus makes the identification of such products easier.

77      As the ECHA states, that explanation is supported by the second paragraph of page 219 of Chapter R.7b of the ECHA Guidance, from which it is apparent that the results of kinetic studies, such as a substance’s degradation rate, must be obtained through such studies being conducted at an environmentally ‘relevant’ temperature. That temperature is 12 °C by default, but may be higher where the transformation or degradation products of the substance in question are to be determined. Accordingly, that chapter requires the ‘relevant’ conditions to be applied and, in that respect, concedes that a temperature higher than the 12 °C average may be used where the study’s purpose is to identify, as in the present case, a substance’s transformation or degradation products.

78      Second, as regards the argument that 20 °C is within the temperature range set out in paragraph 33 of the OECD 308 guidelines concerning the conduct of the tests in question, it must be stated that, according to that paragraph, the test should be performed in the dark at a constant temperature in the range of 10 °C to 30 °C. As the Federal Republic of Germany states, those conditions are also repeated in point 1.9.1 of section C.24 of the annex to Regulation No 440/2008. The second paragraph of that point clarifies that, to conduct a test such as the OECD TG 308 study, a temperature of 20 °C (+/- 2 °C) is appropriate.

79      Accordingly, the ECHA Board of Appeal was entitled to state that the temperature of 20 °C set by the initial decision was within the limits laid down in the OECD TG 308 guidelines.

80      Third, as concerns the temperature of surface water in the European Union, it should be recalled that, on account of the adversarial nature of the proceedings before the ECHA Board of Appeal, it was for the applicant to demonstrate that the ECHA’s conclusions in the initial decision were vitiated by error (see, to that effect, judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 275). It was thus for the applicant to prove that a temperature of 20 °C in the European Union was unrealistic. Similarly, it is for the applicant to prove before the General Court that the conclusions of the Board of Appeal on that point are manifestly erroneous. In any event, the mere fact that such a temperature is neither constant nor present throughout the surface water of the entire European Union all year long does not permit the inference that that temperature is unrealistic to the point of constituting a manifest error of assessment by the Board of Appeal.

81      It is true, as the applicant indicates, in accordance with the version of the statements on page 206 of Chapter R.7b of the ECHA Guidance available online at the address provided by the applicant in paragraph 39 of the application and which is not disputed by the ECHA, that 12 °C is at present considered by the authorities as the mean temperature of European surface waters and is the temperature which, according to the ECHA Member State Committee, is required to be used as the testing temperature for new simulation degradation tests. It is also true that, on page 59 of Chapter R.11 of the version of that guidance available online at the address provided by the applicant in paragraph 27 of the application and which is not disputed by the ECHA, it is mentioned that the reference temperature for providing results on higher tier tests (and carrying out tests, where appropriate) is 12 °C for surface water.

82      However, as is apparent from paragraphs 76 and 77 above, the second paragraph of page 219 of Chapter R.7b of the ECHA Guidance does not require a temperature of 12 °C to be used where a substance’s transformation or degradation products are to be identified. While it is stated that this is regarded as a reasonable mean temperature for the European Union, it is also stated that, for the purpose of identifying degradation products, a higher test temperature (but one falling within the framework provided by the study guidelines) could be used to overcome potential analytical limitations for the identification and quantification of those degradation products.

83      Similarly, on page 221 of Chapter R.7b of the ECHA Guidance, under the heading ‘Temperature at which to perform new simulation studies’, it is stated that, for tests conducted under Regulation No 1907/2006, the preferred option is to use a temperature of 12 °C where the principal aim of the study is to determine the half-life of the parent molecule. However, if the purpose of the simulation test is principally the identification of metabolites (that is to say, transformation or degradation products), a higher test temperature of 20 °C may be appropriate to accelerate the formation of degradation products and thus to make their identification and characterisation easier.

84      It is not disputed that the purpose of the OECD TG 308 study is precisely to identify UVASORB HEB’s transformation or degradation products and to quantify them, the temperature of 20 °C having been selected to accelerate the formation of such products and thus to make their identification easier, given the slow degradation of the substance in question.

85      Fourth, as regards the applicant’s argument concerning the artificial increase in the concentration of UVASORB HEB’s transformation or degradation products, it must be observed that this is based on the premiss that the temperature of 20 °C stated in the initial decision, and confirmed by the contested decision, is unrealistic and would lead to a concentration of transformation or degradation products that would probably not be formed under real life conditions.

86      First, as explained in paragraphs 70 to 73 above, it is in no way apparent from Annex XIII to Regulation No 1907/2006 that a distinction should be drawn between (i) the ‘relevant’ conditions applied to the assessment of a substance’s PBT or vPvB properties and (ii) the ‘realistic’ conditions used to identify that substance’s transformation or degradation products. On the contrary, since the EU legislature only refers to ‘relevant’ conditions in that annex, it is appropriate to ensure that the temperature of 20 °C used in the present case satisfies that condition, in the light of the test conditions described in section C.24 of the annex to Regulation No 440/2008. Second, as is apparent from paragraphs 80 to 84 above, the applicant has failed to demonstrate that the temperature of 20 °C for surface water was unrealistic at certain times of the year and in certain parts of the European Union.

87      In any event, it is common ground that the test temperature does not affect the studied substance’s degradation pathways. A higher temperature does, however, enable the formation of potential transformation or degradation products of that substance to be accelerated. Accordingly, at a temperature of 12 °C, the speed at which UVASORB HEB degrades is slower, whilst at 20 °C the same potential transformation or degradation products will be formed more quickly.

88      As regards the concentration threshold for potential transformation or degradation products, the ECHA does not dispute that that threshold can be higher when the test temperature increases, so that the 10% concentration threshold ultimately used in the contested decision could more easily be reached at a temperature of 20 °C. However, the applicant has in no way disputed the ECHA’s statement that, at a lower temperature, the same transformation or degradation products would end up being formed over time, at the same final concentration. Nor has the applicant adduced evidence capable of calling that statement into question.

89      In addition, paragraph 41 of the OECD 308 guidelines states that transformation products for which concentrations are continuously increasing during the study should also be considered for identification, as appropriate, even if their concentrations do not exceed the 10% limit, as this may indicate persistence.

90      Therefore, even if a temperature below 20 °C were applied in respect of the OECD TG 308 study, with the result that potential transformation or degradation products of UVASORB HEB could form at lower concentration thresholds, this would not preclude all consideration of those products, as the case may be.

91      It follows from the foregoing that the second plea must be rejected as unfounded, without it being necessary to consider the admissibility of the arguments raised by the applicant in the reply claiming that the ECHA incorrectly interpreted paragraph 41 of the OECD 308 guidelines.

92      As a result, the action must be dismissed as unfounded.

IV.    Costs

93      Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the ECHA.

94      Under Article 138(1) of the Rules of Procedure, Member States which have intervened in the proceedings are to bear their own costs. The Federal Republic of Germany must therefore bear its own costs.

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

1.      Dismisses the action;

2.      Orders 3V Sigma SpA to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA), including those incurred in connection with the proceedings for interim relief;

3.      Orders the Federal Republic of Germany to bear its own costs.

Delivered in open court in Luxembourg on 16 December 2020.

*      Language of the case: English.

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