OPINION OF ADVOCATE GENERAL

PITRUZZELLA

delivered on 27 October 2022( )

Case C‑144/21

European Parliament

v

European Commission

(Action for annulment – Commission Implementing Decision C(2020) 8797 of 18 December 2020 partially granting an authorisation for certain uses of chromium trioxide – Regulation (EC) No 1907/2006 (REACH Regulation) – Article 60(4) – ‘Socio-economic’ authorisation procedure – Analysis of the risk to human health or the environment arising from the use of the substance – Analysis of the absence of suitable alternative substances or technologies)





Table of contents





I. Description of the regulatory environment

II. Background to the dispute

III. The contested decision

IV. Forms of order sought by the parties

V. Examination of the action

A. Arguments of the parties

1. The first branch of the single plea in law, concerning the failure to come to a conclusive judgement on the risks to human health and the environment

2. The second branch of the single plea in law, relating to the failure to ascertain that no suitable alternative substances or technologies were available for uses 2, 4 and 5

3. The third branch of the single plea in law, relating to the wrongful granting of the authorisation despite the shortcomings in the application for authorisation

B. Legal analysis

1. Preliminary remarks

2. Case-law principles relating to analysis of the requirements laid down in Article 60(4) of the REACH Regulation

3. The first branch of the single plea in law, concerning the failure to come to a conclusive judgement on the risks to human health and the environment

(a) Analysis of the contested decision

(b) Assessment

4. The second branch of the single plea in law, relating to the failure to ascertain that no suitable alternative substances or technologies were available for uses 2, 4 and 5

(a) The approach applied by the Commission in the contested decision

(b) The analysis as to whether suitable alternative substances or technologies exist

(c) The limitation of uses by reference to key functionalities

5. The third branch of the single plea in law

C. Conclusion reached on the action

VI. The request to maintain the effects of the contested decision

VII. Costs

VIII. Conclusion





1. The present case gives the Court of Justice an opportunity to provide clarification as to the analysis to be carried out by the European Commission within the system developed by the REACH Regulation, ( ) concerning the registration, evaluation, authorisation and restriction of chemicals, in relation to the conditions under which that institution may grant an authorisation for a substance of very high concern, such as, in the present case, chromium trioxide.

2. In the present case, the European Parliament has brought an action seeking the annulment of Commission Implementing Decision C(2020) 8797 of 18 December 2020 partially granting an authorisation for certain uses of chromium trioxide under the [REACH] Regulation (Chemservice GmbH and others): ‘the contested decision’.

3. The present case is of considerable importance in determining the precise scope of the analysis to be carried out in the context, in particular, of the ‘socio-economic’ authorisation procedure for the use of a substance of very high concern, provided for in Article 60(4) of the REACH Regulation. Indeed, the arguments put forward by the Parliament in its application require the Court to assess the analysis carried out by the Commission in the contested decision with regard to both of the requirements laid down in that provision for authorisation of the use of a substance of very high concern within that framework, namely, first, that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance, and second, that there are no suitable alternative substances or technologies.

I. Description of the regulatory environment

4. The REACH Regulation is a key legal instrument governing the regulation of chemicals in the European Union. It is apparent from Article 1(1) of that regulation that its purpose 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. ( ) That high level of protection is ensured by means of an integrated system for monitoring manufactured chemical substances, imported or placed on the market in the European Union, based on the registration, evaluation and authorisation of those substances and possible restrictions on their use. ( )

5. It is stated in Article 1(3) of the REACH Regulation that, first, the regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment, and, second, its provisions are underpinned by the precautionary principle.

6. As is made clear, inter alia, in recitals 69 and 70 of the REACH Regulation, that regulation makes substances of very high concern subject to careful attention. Those substances are thus subject to the authorisation regime laid down in Title VII of the REACH Regulation. Article 55 of that regulation states that the aim of the authorisation regime is ‘to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable’.

7. In consequence, as set out in Articles 56 and 58 of the REACH Regulation, substances of very high concern included in Annex XIV to that regulation cannot be used or placed on the market for a use by manufacturers, importers or downstream users after a specified date, unless the use has been authorised or one of the other conditions indicated in the REACH Regulation applies. ( )

8. Manufacturers and importers can submit applications for authorisation to place a substance on the market, to use that substance themselves and to grant its use to their downstream users. ( ) While those applications are made to the European Chemicals Agency (‘ECHA’), ( ) established by that regulation to help administer its provisions, it is the Commission that takes the decision. ( ) Authorisation decisions specify, inter alia, the use(s) covered, the time period for review of the authorisation and the conditions to which the authorisation is subject. ( )

9. Article 60 of the REACH Regulation establishes two alternative procedures by which an authorisation can be granted by the Commission for the use of substances of very high concern: on the one hand, under Article 60(2) of the REACH Regulation, authorisation is granted if the risk to human health or the environment arising from the use of a substance is adequately controlled (an ‘adequate control’ procedure) and, on the other hand, Article 60(4) of the REACH Regulation lays down a ‘socio-economic’ procedure.

10. In that regard, Article 60(4), (5) and (7) of that regulation states that:

‘…

4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment [(“RAC”)] and the Committee for Socio-economic Analysis [(“SEAC”)] referred to in Article 64(4)(a) and (b):

(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

(b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

(c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

(d) available information on the risks to human health or the environment of any alternative substances or technologies.

5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:

(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

(b) the technical and economic feasibility of alternatives for the applicant.

…

7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.’

11. Article 62 of the REACH Regulation, entitled ‘Applications for authorisations’, states as follows in paragraph 4(d) and (e):

‘An application for authorisation shall include the following information:

…

(d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

(e) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate, information about any relevant research and development activities by the applicant; …’

12. The Commission takes the decision on the application for authorisation following the procedure set out in Article 64 of the REACH Regulation. In particular, this involves, pursuant to Article 64(2) of that regulation, a public consultation, which gives third parties the opportunity to submit information on alternative substances or technologies. Under Article 64(3) and (4) of the REACH Regulation, RAC and SEAC, bodies operating within the ECHA and entrusted with various tasks, ( ) must give their opinions on relevant aspects of the application. Under Article 64(8) of the REACH Regulation, the Commission prepares a draft decision within three months of receipt of these opinions and adopts the final decision in accordance with the applicable committee procedure. ( )

II. Background to the dispute

13. Chromium trioxide is a substance of very high concern under the REACH Regulation. It is listed in Annex XIV to that regulation. The uses of this substance are subject to the authorisation requirement. ( )

14. In 2015 Lanxess Deutschland GmbH and other operators (‘the applicants’) submitted an application to obtain authorisation for six categories of uses of chromium trioxide.

15. The six categories of uses for which authorisation was requested are the following: uses of chromium trioxide in the formulation of mixtures (‘use 1’); in functional chrome plating (‘use 2’); in functional chrome plating with decorative character (‘use 3’); in surface treatment for applications in the aeronautics and aerospace industries (unrelated to functional chrome plating or functional chrome plating with decorative character) (‘use 4’); in surface treatment (except passivation of tin-plated steel (electrolytic tin plating – ETP)) for applications in various industry sectors, namely architectural, automotive, metal manufacturing and finishing, and general engineering (unrelated to functional chrome plating or functional chrome plating with decorative character) (‘use 5’); and in passivation of tin-plated steel (ETP) (‘use 6’).

16. On 30 September 2016 the Commission received the opinions on the application adopted by RAC and SEAC.

17. On 27 March 2019 the European Parliament adopted a resolution objecting to an earlier draft of the decision. In essence, the Parliament’s objection was based on the fact that there were serious gaps in the information submitted by the applicants and thus the fulfilment of the requirements for granting an authorisation, in particular whether or not safer alternatives were available, could not be properly assessed. In the Parliament’s view, this was all the more so since the description of the intended uses of the substance at issue was so generic as to result in an extremely broad scope of the authorisation. In this regard, the Parliament also took the view that the approach of the Commission, aimed at remedying gaps in the application by requiring the applicants to provide the missing data in the review report, was not in line with the case-law of the EU courts. ( )

18. As a result of that resolution, the Commission excluded use 3 (functional chrome plating with decorative character) from the scope of its draft decision. However, for the rest, the Commission essentially maintained its original approach, which consisted in adopting the authorisation while imposing certain conditions and restrictions and, on 18 December 2020, it adopted the contested decision.

III. The contested decision

19. In the contested decision, the Commission established, first, that authorisations for chromium trioxide could only be granted under Article 60(4) of the REACH Regulation. ( )

20. As a first step, the Commission therefore analysed, in recitals 9 to 15, the first of the two requirements laid down in that provision, namely whether the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance.

21. The Commission stated in recital 9 of the contested decision that ‘in its opinions on uses 1, 2, 4 and 5, RAC concluded that the risk management measures and operational conditions as described in the application are not appropriate and effective in limiting the risks to workers’.

22. Specifically, in recital 10 of that decision, the Commission noted that, concerning ‘uses 1, 2, 4 and 5, RAC further concluded that there are significant uncertainties regarding worker exposure due to limited availability of measured exposure data. RAC further concluded that a prevalent lack of contextual information has made it difficult to establish a link between the operational conditions and risk management measures described in the application and the claimed exposure levels for specific tasks and sites, thereby preventing RAC from further evaluation. Those uncertainties concern the reliability and representativeness of the exposure data and how it relates to the specific risk management measures in place, particularly for use 4 where, in addition to bath immersion, different activities including spraying, rolling, brushing and machining operations are covered by the application and the applicants have not been able to fully assess the combined exposure related to all those tasks. Nevertheless the Commission notes that those uncertainties did not prevent SEAC from further analysing the application’.

23. In recital 11 of the contested decision, the Commission stated that, concerning ‘uses 1, 2, 4 and 5, RAC further concluded that uncertainties also exist in the assessment of exposure of the general population to the substance, via the environment, at the local scale, particularly regarding emission of chromium (VI) via wastewater. This is particularly relevant as regards oral exposure via drinking water. However, RAC considered the provided assessment of risks to the general population via the environment to be sufficient for further analysis by SEAC, noting that the approach by the applicants is based on assumptions that are likely to overestimate the risks to the general population’.

24. In recital 12 of the contested decision, the Commission noted that ‘in its opinions on uses 1, 2, 4 and 5, due to the uncertainties in the assessment of risks to workers and to the general population via the environment, RAC recommended imposing additional conditions and monitoring arrangements. The Commission, having evaluated RAC’s assessment, concurs with that conclusion’.

25. In recital 15 of the contested decision, the Commission then noted that ‘in its opinions as regards uses 1, 2, 4, 5 and 6 of chromium trioxide as described in the application SEAC concluded that the overall socio-economic benefits arising from each of those uses outweigh the risk to human health arising from those uses’

26. Then, in recitals 16 to 24 of the contested decision, the Commission analysed the second requirement laid down in Article 60(4) of the REACH Regulation for granting of an authorisation, namely the availability of suitable alternative substances or technologies.

27. As regards uses 2, 4 and 5, the Commission noted in recital 18 of that decision that ‘in its opinions on uses 2, 4 and 5, SEAC concluded that there are no suitable alternative substances or technologies. However, due to the very broad scope of the uses applied for, SEAC could not exclude possible uncertainty with regard to the technical feasibility of alternatives for a limited number of specific applications that are covered by the description of those uses. The Commission concurs with SEAC’s conclusion’.

28. Consequently, in recital 19 of the contested decision the Commission stated that ‘in order to ensure that the authorisation covers only those uses for which no suitable alternatives are available, it is necessary to further specify the description of uses 2, 4 and 5 by aligning it with the conclusions of the analysis of alternatives as presented in the application and as assessed by SEAC. The Commission considers that the applicants have discharged their burden of proof in demonstrating the absence of suitable alternatives as regards uses 2, 4 and 5, only with regard to such limited scope of the uses’.

29. In recital 20 of that decision, the Commission added that ‘therefore, the description of uses 2, 4 and 5 should be further specified by referring to uses where any of the … key functionalities is necessary for the intended use’ and listed a series of key functionalities for uses 2, 4 and 5. ( )

30. On the basis of that reasoning, the Commission concluded in recital 22 of the contested decision that, having evaluated SEAC’s assessment, and taking the above considerations into account, it agreed with the conclusion that there were no suitable alternative substances or technologies for uses 2, 4 and 5.

31. In recital 26 of the contested decision, the Commission asserted that it had ‘based its assessment on all relevant scientific evidence currently available, as assessed by RAC, and based its conclusions on the existence of a sufficient weight of evidence allowing it to conclude’. Nevertheless, the Commission considered that additional scientific evidence would allow it to perform its assessment on a more robust or broad evidentiary base in the future and that it was therefore appropriate to require the generation of additional exposure and emission information.

32. In recital 27 of the contested decision, the Commission then stated that, furthermore, in order to facilitate the enforcement of the decision, with regard to uses 2, 4 and 5, it was necessary to require the authorisation holders’ downstream users to include, in the notification sent to ECHA pursuant to Article 66(1) of the REACH Regulation, ( ) an explanation of the key functionalities listed in the contested decision which are necessary for their use, including a justification as to why they are necessary for that use.

33. Based on these considerations, in Article 1(1) of the contested decision the Commission granted an authorisation to the applicants for use 6, uses 2, 4 and 5 only where one of the key functionalities listed in that paragraph is necessary for use, and use 1, for the formulation of mixtures for uses 2, 4, 5 and 6, as authorised.

34. Conversely, on the basis of Article 1(2) to (4) of that decision, an authorisation for chromium trioxide was not granted for uses 2, 4 and 5 where none of the key functionalities indicated therein is necessary for those uses.

35. Under Article 2(2) and (3) of the contested decision:

‘2. The authorisation holders shall develop specific exposure scenarios for representative processes, operations and individual tasks (including automatic versus manual systems and open versus closed systems and combinations thereof), describing risk management measures and operational conditions to control worker exposure to chromium (VI) and its emissions into the environment, representative for all sites at which the authorised uses take place, in each of the specific scenarios. The exposure scenarios shall contain information on the exposure levels resulting from the implementation of those risk management measures and operational conditions. The authorisation holders shall select the risk management measures described in the specific exposure scenarios in accordance with Article 5 of Directive 2004/37/EC [of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ 2004 L 158, p. 50)]. The authorisation holders shall document and justify the selection of risk management measures and shall make available the relevant documents to the competent authorities of the Member State where an authorised use takes place upon request.

3. The authorisation holders shall make available the specific exposure scenarios to the downstream users to whom this Decision applies …, in an updated safety data sheet, at the latest on 18 March 2021. The authorisation holders and the downstream users shall apply the risk management measures and operational conditions included in the specific exposure scenarios without undue delay.’

36. Article 5 of the contested decision establishes that, as regards authorisation for uses 2, 4 and 5, the downstream users must include, in the notification to ECHA under Article 66(1) of the REACH Regulation, an explanation of the key functionalities of chromium trioxide listed in Article 1(1) which are necessary for their use, including a justification as to why such key functionalities are necessary for that use.

IV. Forms of order sought by the parties

37. The Parliament is requesting that the Court annul Article 1(1) and (5) and Articles 2, 3, 4, 5, 7, 9 and 10 of the contested decision inasmuch as they concern the authorisations relating to uses 2, 4 and 5 (and use 1, in relation to the formulation of mixtures for uses 2, 4 and 5). In the alternative, it is requesting that the contested decision be annulled in its entirety and that the Commission and ECHA be ordered to pay the costs.

38. The Commission is requesting, primarily, that the Court dismiss the Parliament’s plea seeking the partial annulment of the contested decision. In the alternative, the Commission is requesting that the Parliament’s action seeking the annulment in full of the contested decision be dismissed and, if that request were to be granted, it is requesting that the effects of the contested decision be maintained. The Commission is asking the Court to award costs in its favour.

39. ECHA was granted leave to intervene in the present proceedings by order of the President of the Court of 17 September 2021, and submitted a statement in intervention in support of the Commission.

V. Examination of the action

A. Arguments of the parties

40. In support of its action, the Parliament relies on a single plea in law, alleging a breach of Article 60(4) and (7) of the REACH Regulation. That single plea is divided into three branches.

1. The first branch of the single plea in law, concerning the failure to come to a conclusive judgement on the risks to human health and the environment

41. In the first branch of its single plea in law, the Parliament alleges that the Commission breached Article 60(4) of the REACH Regulation by authorising uses 2, 4 and 5 of chromium trioxide (and use 1 in relation to the formulation of mixtures for uses 2, 4 and 5) without having carried out a conclusive assessment of the risk to human health and the environment arising from such uses. That failure necessarily vitiated the assessment intended to verify ‘that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance’ required by that provision.

42. It can be seen clearly from recitals 10 to 12 of the contested decision that, concerning uses 1, 2, 4 and 5, there were significant uncertainties regarding the assessment of risks to workers and to the general population via the environment and that, on the basis of those uncertainties, RAC had recommended imposing additional conditions and monitoring arrangements. It follows from recital 10 of the contested decision that those uncertainties were particularly acute as regards the workers’ exposure to the substance, which prevented any meaningful assessment of such risk. According to the RAC opinions, for each use for which authorisation was sought, the information provided by the applicants in order to allow an assessment of the risk to human health and the environment was so incomplete and unrepresentative as to lead that committee to conclude that significant uncertainties existed as to the extent and the level of risk.

43. According to the Parliament, the exposure data provided in the present case by the applicants are not representative and do not comply with the requirements established in Article 62(4)(d) of the REACH Regulation and point 5.2.4 of Annex I to that regulation. While it is true that RAC found that the methodology used by the applicants might explain the low level of representativeness of the data (which represented less than 3% of the companies concerned), it did not explicitly accept or justify this in its opinions.

44. The Parliament adds that providing measured exposure data (or, at least representative modelling data) as well as a proper description of the operational conditions and risk management measures for all the uses covered by the application, as required by Article 62(4)(d) of the REACH Regulation and point 5.2.4. of Annex I to that regulation, would have been possible had the application not been exceedingly broad in scope. The Parliament further submits that the Commission failed to state reasons in the contested decision for concluding that, despite the lack of representativeness of the data and the serious uncertainties identified, the applicants had discharged their burden of proof. The Commission simply notes that the uncertainties did not prevent SEAC from further analysing the application.

45. Specifically in order to remedy those deficiencies, Article 2(2) of the contested decision made the authorisation conditional upon the provision in the review report of the core data (exposure scenarios and the related risk management measures) that were missing in the assessment of the risk in question. The contested decision itself therefore shows, first, that a significant amount of information required to be provided by the applicants under Article 62(4)(d) of the REACH Regulation and mandatory for the assessment under Article 60(4) of that regulation was not available to the Commission at the time when the authorisation was granted and, second, that the conditions imposed in Article 2(2) of the contested decision were effectively aimed at remedying the shortcomings in the application for authorisation and in the assessment carried out on the basis of that application. Furthermore, the Commission has misinterpreted the meaning of Articles 56 and 66 of the REACH Regulation when it presents those provisions as if they would allow crucial information for the initial authorisation to be provided only by downstream users after that authorisation has been granted.

46. Under those circumstances, the Commission could not come to a sound and conclusive judgement as to whether ‘the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance’, as required by Article 60(4). However, no authorisation may be granted if the Commission has not conclusively ascertained that that condition is satisfied, and shortcomings in an application for authorisation cannot be remedied through imposing conditions in the authorisation decision.

47. The Commission contends that it has not breached its obligation to carry out a conclusive assessment of the risk to human health and the environment, as required by Article 60(4) of the REACH Regulation.

48. By definition, any scientific assessment involves uncertainty. The fact that uncertainties exist in no way vitiates a scientific assessment. It is not therefore incumbent on the Commission to eliminate any uncertainty or to insist that the applicant for authorisation proves a negative.

49. Despite the uncertainties referred to by the Parliament, as already identified in the RAC opinion and recognised in the contested decision, the Commission nevertheless considers that the applicants have discharged their burden of proof. The Commission felt it was able on that basis to conclude that the socio-economic benefits outweigh the risk to human health or the environment. That assessment is not intended to prove adequate management of the risks in each individual case where the substance is used, but should enable a proper balancing exercise between the benefits and risks.

50. The information provided in the chemical safety report was sufficient to carry out an appropriate risk assessment by RAC, enabling SEAC to conclude on the benefit/risk assessment and ultimately allowing the Commission to verify that the condition that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance was satisfied. The Commission does not dispute that there were uncertainties but argues that, by scientific expert judgement, those uncertainties were not of such nature as to prevent a conclusion that the first condition for authorisation was met.

51. With regard in particular to uncertainties related to workers’ exposure, the Commission first explained the reasons why, notwithstanding the limited availability of measured exposure data in the chemical safety report, RAC considered that the information provided was sufficient for the assessment and for SEAC to continue with the balancing exercise of comparing benefits to the risks.

52. First of all, as regards use 1, RAC proposed to use the applicants’ estimated maximum combined exposure level of 0.5 μg/m3 for further SEAC assessment. As regards uses 2, 4 and 5, due to the wide range of potential downstream users that could benefit from the application and the subsequent authorisation (as far as use 2 is concerned, the applicants reported up to 1 590 sites in different Member States of the European Union), RAC required some clarifications from the applicants. Following those clarifications, RAC acknowledged that the limited number of retained data was also due to the methodology used (focusing on personal monitoring data as opposed to using static monitoring data), which consequently led to the use of only a selection of the available dataset.

53. RAC also noted that extensive data on exposure available in recent literature provided by the applicants, including some independent studies, gave credibility to the applicants’ exposure assessment (uses 2, 4, 5) or indicated to SEAC that a worst-case approach should be adopted (use 1). The applicants also provided modelled data for all uses, which were considered by RAC to support the measured data.

54. Second, the applicants could not be expected – and it would also not be proportionate – to provide measured exposure data from over 1 500 downstream users’ sites, given that those downstream users might not necessarily all be known at the time when the authorisation is granted.

55. Third, the fact that the contested decision contributes to reducing exposure by improving workers’ protection and thus is consistent with the aims of the authorisation is illustrated by the fact that the relevant exposure values of 2 μg/m3 (for uses 2, 4 and 5) and 0.5 μg/m3 (for use 1) are, respectively, one fifth and one twentieth of the EU binding occupational exposure values for chromium (VI) compounds currently applied under the applicable regulations.

56. Fourth, RAC also recommended additional conditions and monitoring arrangements that are reflected in the contested decision, the aim of which is to further reduce workplace exposure.

57. In terms of the applicants’ alleged failure to discharge their burden of proof, the Commission notes that the REACH Regulation does not set up a ‘beyond reasonable doubt’ or ‘absence of uncertainties’ standard of proof required from applicants. Rather, a sufficient weight of evidence must allow a conclusion by expert judgement properly grounded on reliable and trustworthy information.

58. According to the Commission, the Parliament completely disregards the fact that the scientific assessment intended to determine whether the first requirement of Article 60(4) of the Reach Regulation has been fulfilled has also been carried out by SEAC. In its opinions SEAC assessed the benefit-risk ratio, explaining the reasons why the data assessed by RAC were sufficient and providing a conclusion on the matter. In particular, SEAC, given the uncertainties pointed out by RAC and in order to test the robustness of the benefit-risk ratio, set up an additional conservative scenario (worst case scenario), on the basis of which it concluded that it had no reservations to raise that would change the validity of the applicants’ conclusion that the overall benefits of continued use of chromium trioxide outweighed the risk to human health. The Commission thoroughly reviewed the RAC and SEAC opinions and found them full, consistent and relevant in this respect.

59. Contrary to the allegations made by the Parliament, the monitoring requirements set out in Article 2(2) of the contested decision are not intended to remedy the deficiencies of the application. The goal of Article 2(2) of the contested decision is to require generation of additional exposure and emission information, as recommended in the ECHA opinions. This is aimed, first, at providing a more detailed representation of the processes concerned, operational conditions and risk management measures for individual tasks from authorisation holders in cooperation with their downstream users. This is also consistent with the overall logic of REACH, which embodies a principle of continuous improvement, and specifically aims to improve the quality of chemicals regulation over time by the continuous generation and improvement of data on substances for regulatory purposes.

60. In its statement in intervention in support of the Commission, ECHA claims, first, that the data provided by the applicants were representative of workers’ exposure. First of all, although ECHA accepts that RAC indeed considered that it could not be concluded whether the measured worker exposure data provided by the applicants was representative for all downstream users, it emphasises that the committee did not solely rely on the measurement data presented by the applicants. RAC also considered data stemming from publicly available literature and studies, collected both by the rapporteur and by the applicants, as well as modelled exposure data provided by the applicants.

61. In its opinions RAC highlighted a number of uncertainties in relation to uses 2, 4 and 5 stemming from the data provided. However, RAC considered that the combined exposure level of 2 μg Cr(VI)/m3 calculated by the applicants as an 8-hour maximum combined individual exposure value was a reasonable worst-case assumption. That is why RAC was able to conclude its assessment on worker exposure tied to uses 2, 4 and 5 based on the data provided and concluded that the exposure level of 2 μg Cr(VI)/m3 calculated by the applicants was an appropriate starting point for the socio-economic analysis carried out by SEAC.

62. Second, ECHA considers that, to the extent that it relies on RAC’s assessment on exposure of the general population, the contested decision is based on data which are sufficiently reflective of the exposure that the general population is likely to face due to the continued use of chromium trioxide.

63. Third, ECHA asserts that the Commission did have at its disposal sufficient information based on the assessment by RAC and SEAC to decide whether the benefits of granting the authorisation outweighed the costs tied to the risks of the authorised uses. Specifically, in its assessment, SEAC agreed with RAC that the calculations based on the estimation of exposed populations and duration of exposure as provided by the applicants could be used to quantify the estimated statistical cancer cases and thus the costs of continued use of the substance. However, due to the remaining uncertainties SEAC decided, when assessing the costs of the continued use of the substance, to opt for the worst-case scenario. For the calculation of human health impacts for workers this resulted in an increase in the monetised impacts on health of workers as compared to the human health impacts calculated by the applicants. Even when basing the assumption of costs associated with the continued use of the substance on such a worst-case approach, SEAC in all cases supported the applicants’ assessment that the benefits of continued use outweighed the resulting risks to human health.

2. The second branch of the single plea in law, relating to the failure to ascertain that no suitable alternative substances or technologies were available for uses 2, 4 and 5

64. In the second branch of its single plea in law, the Parliament asserts that the contested decision was adopted in breach of Article 60(4) of the REACH Regulation inasmuch as the Commission failed to ascertain – as required by that provision – that no suitable alternative substances or technologies were available for uses 2, 4 and 5 for which authorisation was sought. Specifically, the Parliament challenges the approach applied by the Commission whereby it inserted a reference in recitals 18, 19 and 20 and in Article 1 of the contested decision to the ‘key functionalities necessary for the intended use’, in order to restrict the scope of the authorisation because of the uncertainties regarding the availability of suitable alternatives.

65. Article 60(4) of the REACH Regulation places the burden of proof as to the existence of suitable alternatives on the party applying for authorisation. This implies that the applicants bear the risk of a potential impossibility to determine whether alternatives are available. As a consequence, the assessment intended to determine the existence of alternatives must allow the Commission to determine a conclusive outcome in this regard before an authorisation decision is adopted. Conversely, uncertainty about the existence of suitable alternatives prevents the Commission from granting an authorisation. The possibility of attaching certain conditions to an authorisation does not allow the Commission to remedy shortcomings in the analysis of the alternatives submitted by the applicants, or deficiencies or gaps in the Commission’s own assessment.

66. In the present case, although the Commission stated in recital 19 of the contested decision that the applicants had discharged their burden of proof in demonstrating the absence of suitable alternatives as regards uses 2, 4 and 5, it considered that this was the case only ‘with regard to such limited scope of the uses’, that is to say within the more restricted scope of such uses as determined by the Commission itself. The contested decision therefore imposes conditions on the authorisation with the aim of remedying the shortcomings in the application in the analysis of the alternative solutions presented by the applicants (namely the submission of data that are very general and scarce in the light of very broad descriptions of the categories of uses).

67. Furthermore, the reference to ‘key functionalities necessary for the intended use’ is not conclusive as regards the absence of suitable alternatives, which must be established before an authorisation is granted. In other words, by authorising chromium trioxide for a given use where any of the ‘key functionalities’ listed in the contested decision is necessary for such use, the Commission did not establish whether any of those functionalities is indeed necessary for the use in question, that is to say whether this cannot be achieved with an alternative technique or substance, or in any event without the substance for which the authorisation is sought.

68. The inadequacy of the analysis as to the existence of suitable alternatives is confirmed by recital 27 and Article 5 of the contested decision. The existence of such a notification requirement demonstrates that, even within the allegedly more restricted scope defined by the Commission through the concept of ‘key functionalities’, there still remains uncertainty about the lack of suitable alternatives as regards intended uses 2, 4 and 5. In fact Article 1(1), read in conjunction with Article 5, of the contested decision leaves to downstream users the task of explaining the key functionalities listed in the decision and proving that any of those functionalities is indeed necessary for the intended uses. In other words, downstream users are required to show, when using chromium trioxide, that such use requires one of the key functionalities for which there is no alternative solution according to the authorisation decision. This shows that the analysis of the availability of suitable alternatives conducted ahead of the contested decision as regards intended uses 2, 4 and 5 had in reality remained inconclusive and it is now left to downstream users to demonstrate that chromium trioxide is indeed ‘necessary’ for those purposes, and therefore that no suitable alternatives are available. The additional information that downstream users are required to provide under the contested decision is in fact intended to assess whether the condition that there are no alternative solutions for the intended uses is met, but ex post facto, only after those uses have been authorised by the Commission.

69. Moreover, the insertion of the reference to the ‘key functionalities’ does not amount to a genuine restriction of the scope of the authorisation granted. Since the Commission has not established in the contested decision when and under which circumstances those ‘key functionalities’ are necessary for the uses at issue, the corresponding reference is no more than a tautology, which merely recalls the general requirements of Article 60(4) of the REACH Regulation, namely that the substance may only be authorised if it is necessary for the intended use. This is all the more the case since the ‘key functionalities’ listed in the contested decision are essentially all the functionalities of chromium trioxide for uses 2, 4 and 5, as identified by SEAC in its opinions. Nowhere in the contested decision is it specified under which circumstances those functionalities are ‘necessary’, that is to say that suitable alternatives are not available, with the result that use in a specific application is permitted. That assessment is left entirely to downstream users.

70. It follows from all the above that the Commission failed to ascertain that no suitable alternatives existed before granting the authorisation, as required by Article 60(4) of the REACH Regulation, and that, therefore, the contested decision was adopted in breach of that provision.

71. The Parliament added that, according to publicly available sources, and indeed from the very moment when the application for authorisation was granted, alternative substances and/or technologies for various individual applications covered by uses 2, 4 and 5 were indeed present on the market. In accordance with the obligation to carry out an examination – even ex officio – of the conditions laid down in Article 60(4) of the REACH Regulation, the Commission should have examined those possibilities before granting the authorisation and established whether they were ‘appropriate’. However, the contested decision contains no reference whatsoever to such an examination.

72. The Commission asserts that it has not failed in its obligation to verify that no suitable alternatives were available for the uses authorised, as required by Article 60(4) of the REACH Regulation.

73. The Commission notes that Article 62(3) of the REACH Regulation provides that applications may be made for ‘one or several uses’. There is no provision in Title VII of the REACH Regulation setting out rules on the way the use should be described in the application for authorisation or about the level of detail required. It is for the applicants to define the use or uses for which authorisation is sought. This possibility for upstream actors (generally manufacturers or importers of substances) to apply for the whole supply chain (‘upstream applications’) makes it possible to streamline the authorisation system.

74. The Commission believes that, in this context, the following core question arises: is it sufficient for the applicant to prove that no alternative substance or technology will be suitable to meet all downstream needs or must the Commission verify that no alternative substance or technology would be suitable to satisfy every specific user in different sectors, given their specificities? After having applied the first approach in the authorisation decisions adopted initially, the Commission currently applies a halfway approach.

75. In the present case, the Commission, relying on all available information, considered that there was reliable evidence to demonstrate generally and horizontally that there were no suitable alternatives for uses 2, 4 and 5 as defined in the application for authorisation with reference to all the sectors identified. However, it also considered that it had not been proven by the applicants that there were no suitable alternatives for each and every possible downstream utilisation that could potentially exist in those different sectors. In particular, ECHA and the Commission verified that the substance had certain specific functions and technical characteristics that could not feasibly be performed by any alternative in the context of uses 2, 4 and 5. However, ECHA and the Commission could not fully and reliably verify that every downstream user and every downstream utilisation in existence that would be covered by the authorisation technically necessitated those specific functions and technical characteristics. The Commission did assess and find that those technical characteristics were essential for product requirements, for the safety and regulatory compliance of equipment, and that accepting a significantly lower quality would not be technically feasible across the scope of uses 2, 4 and 5 and with full regard to different sectors or different types of downstream uses. The Commission also considered the fact that in complex supply chains and manufacturing processes, it is essential that the substance meets all requirements as the production steps are interlinked and cannot be split into different segments.

76. The Commission therefore fully assessed the potential alternatives to the use of the substance, and conducted a detailed examination of the full scope of uses 2, 4 and 5, including the different sectors and types of downstream use covered by the uses for which authorisation was sought. It adopted a decision that, for each specific use, listed the key functionalities of the substance that no alternatives could viably provide, which it considered necessary for that use, and authorised the respective uses only with respect to those for which those key functionalities were necessary.

77. Hence, the contested decision constitutes only a partial authorisation (and also a partial rejection) of the application for authorisation, as is clear from Article 1(2) to (4) of that decision. All downstream users purporting to be using the substance under the authorisation must report their uses under the authorisation to ECHA, and must indicate which key functionality(ies) of the substance is technically necessary for their activities, including a justification. The competent authorities in the Member States, which have access to the ECHA register of downstream users, are required by the REACH Regulation to ensure it is correctly implemented and enforced. By contrast, the Commission did not perform a separate assessment of alternative solutions for each and every downstream user or product (which would have meant thousands or possibly millions of separate assessments, depending on the level of specificity), which is by no means required by the REACH Regulation. The role of competent authorities, pursuant to the provisions of the REACH Regulation itself, is to verify that downstream users are actually performing a use of the substance covered by the authorisation and that they are not performing other non-authorised uses. There are no considerations on or analysis of the availability of alternatives in that notification to ECHA.

78. Contrary to what the Parliament asserts, the condition in Article 5 of the contested decision in no manner requires downstream users to provide data as regards the suitability of alternatives. Rather, that provision requires that they demonstrate to the competent authorities that those key functionalities of chromium trioxide are actually needed for their use. It is for downstream users to notify their specific utilisation and declare to ECHA what industrial, chemical or other process they use in their activities that (by regulation or technically) necessitates a listed key functionality. The Commission further argues that the Parliament cannot draw arguments from the abovementioned Commission v Sweden judgment. That judgment would not prevent the Commission from limiting the scope of its authorisations using objective criteria.

79. The Commission then states that if the Court were to require a more detailed, specific and granular assessment of downstream utilisations covered by an application for authorisation than is currently conducted, the whole authorisation process would become much more complex than it already is. On the one hand, this would be contrary to the objective of the REACH Regulation of promoting the competitiveness of EU industry, taking special account of the potential impact on small and medium-sized enterprises. On the other hand, a more demanding regime for assessing suitable alternatives would exceed the administrative capacities of ECHA, which is explicitly taken into account in the REACH Regulation ( ) and would make it necessary to limit the number of substances subject to authorisation. An increase in assessments of alternatives would have the effect of stalling the identification of new substances of very high concern. In line with the principle of progressivity, the Commission’s discretionary assessment should become more demanding over time. The approach to the assessment of applications for authorisation implemented by the Commission and ECHA is a result of years of experience and is based on a highly delicate balancing of scientific and socio-economic considerations, and the multiple objectives pursued by the REACH Regulation.

80. Lastly, the Parliament’s reference to publicly available sources mentioning substitute solutions for chromium trioxide concerns a survey by the Federal Institute for Occupational Safety and Health of Germany published in 2020, that is to say 5 years after the application for authorisation was lodged. The Commission disputes the Parliament’s reading of that study.

81. In its statement in intervention in support of the Commission, ECHA first stated that SEAC considered in its opinion that the applicants had made an extensive assessment of alternatives, especially when it came to the aspect of technical feasibility. It is true that SEAC found that the applicants’ approach with regard to uses 2, 4 and 5 was not fully satisfactory. Nonetheless, that committee agreed with the applicants’ conclusion that for all three uses overall, technically feasible alternatives did not seem to exist before the sunset date.

82. Second, ECHA considers that the applicants have sufficiently demonstrated that there are no suitable alternatives to the uses as delineated through reference to the key functionalities. To reduce the uncertainty regarding instances where alternatives may already exist, the Commission restricted the scope of the authorisation to the uses that require technical functionalities which cannot be replaced by existing alternatives. Those key functionalities constitute objective criteria. Downstream users therefore only need to provide the enforcement authorities with information showing that, due to objective technical requirements or regulatory standards, there is a need for the key functionality. No subjective assessment as to whether an alternative exists by either downstream users or the enforcement authorities is necessary.

83. It was the applicants who determined those key functionalities, when defining the use in the application for authorisation and analysing the alternatives available. It was also the applicants who demonstrated that there were no existing alternatives for the uses applied for in cases where such key functionalities were necessary.

3. The third branch of the single plea in law, relating to the wrongful granting of the authorisation despite the shortcomings in the application for authorisation

84. By the third branch of its single plea in law, the Parliament claims that the contested decision was also adopted in breach of Article 60(7) of the REACH Regulation, which stipulates that an authorisation may be granted only if the application is submitted in accordance with the requirements of Article 62(4) of the REACH Regulation. In the present case, given the gaps and imprecisions in the application for authorisation, the authorisation was granted in breach of that provision.

85. On the one hand, it follows from the points raised in relation to the second branch of the single plea in law that the initial application for authorisation did not describe the intended uses in a sufficiently precise manner, and consequently did not include all the information relevant to the analysis of alternatives and that it therefore did not comply with the provision in Article 62(4)(e) of the REACH Regulation. On the other hand, it appears from the points raised in the first branch of the single plea in law that the initial application for authorisation did not include all the information relevant to assess the risk to human health and the environment from the use of the substance in question and hence did not comply with the provisions of Article 62(4)(d) of the REACH Regulation.

86. The Commission contends, on the contrary, that the applicants’ application for authorisation complied with Article 60(7) of the REACH Regulation, which was confirmed by the fact that both RAC and SEAC considered that, despite some deficiencies, the application met the criteria set out in that article.

B. Legal analysis

1. Preliminary remarks

87. By its action, the Parliament is seeking the partial annulment of the contested decision inasmuch as it concerns the authorisations relating to uses 2, 4 and 5 (and use 1, in relation to the formulation of mixtures for uses 2, 4 and 5) of chromium trioxide. In the alternative, should the Court consider that the authorisation for use 6 granted in that decision is inextricably linked to the authorisations for other uses, the Parliament is seeking the annulment of the contested decision in its entirety.

88. In that regard, it should be noted, as a preliminary point, that settled case-law establishes that the partial annulment of an EU act is possible only if the elements for which annulment is sought can be severed from the remainder of the act. On that point, the Court has repeatedly held that the requirement of severability is not satisfied in the case where the partial annulment of an act would have the effect of altering its substance. ( )

89. In the present case, the contested decision appears to be a bundle of individual authorisations for specific uses. It follows that, except for use 1, for which the authorisation appears to be related to other uses, ( ) any annulment of the authorisation for a specific use would not affect the authorisation granted for another use and would not therefore alter the substance of the act itself.

90. In my view, it follows that the Parliament’s application must be considered admissible inasmuch as it seeks partial annulment of the contested decision in relation to uses 2, 4 and 5 (and to use 1, in so far as it concerns the formulation of mixtures for uses 2, 4 and 5) of chromium trioxide.

91. Having said that, before analysing in detail the arguments raised by the Parliament in the three branches into which its single plea in law is divided, I consider it appropriate to reiterate some principles established by the case-law concerning the analysis that must be carried out in the context of the ‘socio-economic’ authorisation procedure laid down in Article 60(4) of the REACH Regulation. These case-law principles provide important guidance that I will then apply to analyse the said arguments raised in the case.

2. Case-law principles relating to analysis of the requirements laid down in Article 60(4) of the REACH Regulation

92. First, it should be noted that the EU courts have made it clear that, in accordance with Article 60(4) of the REACH Regulation, read in conjunction with recital 69 thereof, ( ) in a ‘socio-economic’ authorisation procedure, it falls to an applicant for authorisation to show that the two conditions required for an authorisation to be granted have been met. ( )

93. That classification of the burden of proof as being the responsibility of the applicant for authorisation means that the applicant bears the risk of any impossibility of establishing whether a conclusion can be reached in relation to one or both of the conditions laid down in Article 60(4) of the REACH Regulation. ( )

94. In that context, Article 62(4) of the REACH Regulation indicates the information that the applicant for authorisation must submit at the time of the submission of its application. According to that provision, applications for authorisation must be accompanied, in particular, by a chemical safety report. ( ) The report must be prepared in accordance with Annex I to that regulation and cover the risks to human health and/or the environment from the use of the substance in question arising from the intrinsic properties specified in Annex XIV.

95. Specifically, it is stated in point 5.2.4 of the abovementioned Annex I that the estimation of the exposure levels for all human populations (workers, consumers and human beings liable to exposure indirectly via the environment) prepared in the chemical safety report must take into account a number of elements indicated in that point, the first of which concerns ‘adequately measured, representative exposure data’.

96. It also follows from the case-law that, in the context of the examination of the conditions provided for in Article 60(4) and (5) of the REACH Regulation, it is for the Commission to establish whether all the relevant facts and the technical and economic assessments relating to them support the conclusion that the conditions provided for in that provision are indeed fulfilled. ( ) In that context, the Commission has an obligation to consider on its own initiative the relevant information, since it does not act as an arbitrator whose remit is limited to making an award solely on the basis of the information and the evidence provided by the actors involved in the authorisation procedure. In accordance with the obligation to carry out an ex officio examination of the conditions laid down in Article 60(4) of the REACH Regulation, the Commission must, in the context of good administration and taking into account its duty of care, play its part, using the means available to it, in ascertaining the relevant facts and circumstances. ( )

97. In that regard, the Court has held that the opinions of RAC and SEAC have the status of scientific opinions and the Commission is not bound by such opinions. However, the Commission is not prevented from partially or wholly adopting the assessments set out in an opinion of one of the ECHA committees, but nor is it required to reproduce those assessments or to replace them on each occasion with its own reasoning. ( )

98. In that context, however, the Commission cannot adopt an authorisation decision on the basis of mere hypotheses that were neither confirmed nor rebutted by the information at its disposal. ( )

99. Conversely, in order to be able to reach a final conclusion as to whether the two requirements under Article 60(4) of the REACH Regulation have been met, the Commission must first have verified a sufficient number of items of significant and reliable information to be able to conclude either that a requirement has not been met or that, despite the fact that some uncertainties remain, on the date of adoption of the contested decision those uncertainties could be regarded as negligible. ( )

100. If, following examination of the conditions for granting an authorisation provided for in Article 60(4) of the REACH Regulation, there remain uncertainties relating to the scientific assessment which it was possible to dispel neither with the evidence adduced by the applicant for authorisation, at the request of either the Commission or one of the ECHA committees, nor with the information gathered by the Commission or those committees or even by third parties or Member States, it must be concluded that, in principle, that condition is not fulfilled and that the Commission is therefore not entitled to grant an authorisation, even one which is conditional. ( )

101. With regard to the conditions that the Commission may attach to the granting of an authorisation, it follows from the case-law that, in principle, irrespective of their content, the conditions imposed in accordance with Article 60(8) and (9)(d) and (e) of the REACH Regulation cannot purport to remedy any shortcomings in an application for authorisation or in the analysis of alternatives submitted by an applicant for authorisation or any deficiencies in the Commission’s examination of the conditions provided for in Article 60(4) of the REACH Regulation. ( )

102. In other words, the possibility of attaching certain conditions to an authorisation cannot be interpreted as allowing the Commission to leave open the question of whether the conditions of Article 60 of the REACH Regulation have been met and to respond to that situation by attaching to that authorisation conditions purporting to remedy any deficiencies or gaps in the assessment incumbent on it under that latter provision. ( )

103. In examining the conditions provided for in Article 60 of the REACH Regulation, the Commission must establish whether all the relevant facts and the technical and economic assessments relating to them support the conclusion that the conditions provided for in that provision are indeed fulfilled. If that is not the case, the Commission is not entitled to grant an authorisation, even conditional. ( )

104. It is in the light of the case-law principles discussed in the preceding points that the arguments developed by the parties should be analysed.

3. The first branch of the single plea in law, concerning the failure to come to a conclusive judgement on the risks to human health and the environment

105. In the first branch of its single plea in law, the Parliament is arguing, in essence, that the assessment in the contested decision as to whether the first condition of Article 60(4) of the REACH Regulation – namely ‘that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance’ – has been met has necessarily been vitiated by the existence of significant uncertainties in the assessment of risks to workers and the general public via the environment, which are explicitly acknowledged in the contested decision itself and which derive from the unrepresentative and incomplete nature of the information provided in that regard by the applicants in their application for authorisation. The Commission thus failed to make a conclusive assessment of the risks to human health and the environment of chromium trioxide, erred in considering that the applicants had discharged their burden of proof, and sought to make good those deficiencies in the application for authorisation and in the assessment carried out on the basis of that application by means of the conditions imposed.

106. To respond to these complaints, the contested decision must be analysed in detail in the light of the relevant opinions from ECHA’s advisory committees.

(a) Analysis of the contested decision

107. As regards, first, the assessment of the risk for workers of the uses of chromium trioxide, it appears from a reading of recital 10 of the contested decision that the Commission itself explicitly noted that, concerning uses 1, 2, 4 and 5, RAC had concluded in its opinion that there were ‘significant uncertainties’ regarding worker exposure due to limited availability of measured – that is to say based on real data – exposure data provided by the applicants.

108. In the abovementioned recital 10, the Commission also explicitly stated that RAC had further concluded that a ‘prevalent lack of contextual information’ had made it difficult to establish a link between the operational conditions and risk management measures described in the application and the claimed exposure levels for specific tasks and sites, thereby preventing RAC from further evaluation.

109. Still in recital 10, the Commission also noted that those uncertainties concerned ‘the reliability and representativeness of the exposure data and how it relates to the specific risk management measures in place’, particularly for use 4 where, in addition to bath immersion, different activities including spraying, rolling, brushing and machining operations were covered by the application and the applicants had not been able to fully assess the combined exposure related to all those tasks.

110. An analysis of the RAC opinions on uses 1, 2, 4 and 5 provides a more detailed understanding of the considerations contained in recital 10 of the contested decision.

111. Thus, for use 1, the relevant RAC opinion indicates that the committee concluded its analysis regarding exposure by considering that ‘there are significant uncertainties in the worker exposure assessment covering about 30 sites due to the limited (8 measurements) and variable exposure data and the prevalent lack of contextual information’. RAC also noted that these uncertainties ‘could have been reduced by modelled data, which was not, however, provided by the applicants even though it was requested by RAC’. ( )

112. In the same opinion, RAC also found that a linkage between the operational conditions and risk management measures, on the one hand, and the claimed exposure levels, on the other, was not demonstrated by the applicants due to the lack of contextual information on the measurements, preventing further evaluation by RAC. ( ) This also had an impact on the analysis of the appropriateness and effectiveness of the operational conditions and risk management measures described in the application for authorisation, leading RAC to conclude that there were ‘significant uncertainties’ relating to the description of those conditions and measures and their ability to adequately limit the risk to workers. ( )

113. For uses 2, 4 and 5, the corresponding RAC opinions show that the committee noted a discrepancy in each use applied for between, on the one hand, the total number of potential sites which the applicants consider may be covered by the application for authorisation (up to 1 590 sites) and the number of members of the consortium of undertakings that requested the authorisation (Chromium Trioxide REACH Authorization Consortium), over 150 undertakings, and, on the other, the measured exposure data provided (from 6 to 23 sites for uses 1 to 5). ( )

114. It appears from that finding in the abovementioned RAC opinions that the data provided by the applicants regarding the measurement of workers’ exposure in the application for authorisation covered between 0.3% and 1.44% of the sites where the uses of chromium trioxide for which authorisation was sought were carried out.

115. More specifically, for use 2, the corresponding RAC opinion states that the number of potential workplaces in the European Union performing functional chromium plating was estimated by the applicants to be up to 1 590, but they based the exposure assessment of plating activities on the measured data from 23 companies from 7 different countries, representing fewer than 2% of the companies involved in such use. ( )

116. For uses 4 and 5, the corresponding RAC opinions show that the number of potential sites in the European Union performing those uses was estimated by the applicants as up to 374 and 515 respectively, but they based the exposure assessment of surface treatment activities on measured data from 11 companies (representing around 3% of the companies believed by the applicants to be involved in these uses) and study data derived mainly from Western European countries. ( )

117. For all three of those uses, RAC considered in its opinions that although in general the most recent literature data (and in the case of use 2, modelled data provided by the applicants) could be considered to support the applicants’ estimate of a maximum individual exposure value of 2 μg Cr(VI)/m3, both the data available in the literature and the data presented by the applicants showed variation in exposure levels including also exposure levels higher than 2 μg Cr(VI)/m3. This finding led RAC to conclude that there was clear evidence of exposures higher than the proposed limit. ( )

118. For uses 4 and 5, RAC also concluded that for certain activities included in those uses ( ) only modelled data were provided and that the applicants had not been able to fully assess the combined exposure related to all those activities and that RAC considered that measured – that is to say actual – data were instead necessary for a reliable assessment of workers’ exposure.( )

119. For all four of the abovementioned uses (uses 1, 2, 4, and 5), RAC also concluded that the greatest uncertainty stemmed from the lack of a clear link between the operational conditions, risk management measures and exposure values reported for specific tasks and sites, and that it explicitly considered that lack to be a substantial weakness in the application. ( )

120. Second, in terms of the assessment of the risk of indirect exposure for human beings through release of chromium trioxide into the environment, recital 11 of the contested decision shows that the Commission, on the basis of the RAC opinion, considered that uncertainties also existed in the assessment of exposure of the general population to the substance, via the environment, at the local scale, particularly regarding emission of chromium (VI) via wastewater and that this was particularly relevant as regards oral exposure via drinking water.

121. For all four uses in question (namely uses 1, 2, 4 and 5), the corresponding opinions show that RAC concluded that the applicants had not provided an assessment on releases into wastewater and that this had added uncertainty to RAC’s analysis. In those opinions, RAC explicitly considered that that issue should have been addressed more comprehensively in the applicants’ exposure analysis and that therefore there remained uncertainties related to the applicants’ claim that those releases were negligible. The opinions show, moreover, that RAC also considered that the representativeness of the data provided on the inhalation exposure of the general population was uncertain – although that committee considered that the approach applied by the applicants were ‘likely’ to have overestimated the exposure of ‘the majority’ of the population – in that the data provided in that regard by the applicants represented approximately 1% of the companies active in use 2, and less than 2% for uses 4 and 5. ( )

(b) Assessment

122. The analysis of the contested decision and of the RAC opinions carried out in the preceding points shows, first of all, that, as the Commission itself acknowledged in its pleadings, a number of uncertainties remained following the analysis of all the relevant information available, which the Commission itself described in the contested decision as ‘significant’ with regard to exposure, in particular of workers, to chromium trioxide in the context of the uses for which the authorisation had been requested.

123. In that regard, the Commission argues that by definition any scientific assessment involves uncertainties and that this does not in itself vitiate a scientific assessment. However, as is clear from the case-law cited in point 99 above, the Court has unequivocally determined the acceptable degree of uncertainty in the context of an analysis of the conditions of Article 60(4) of the REACH Regulation, specifying that this must be ‘negligible’.

124. However, it appears from the above analysis that in the present case, because the remaining uncertainties regarding exposure to chromium trioxide are ‘significant’, at least as far as workers are concerned, they cannot be regarded as merely ‘negligible’ in the terms of that case-law. Furthermore, neither in the contested decision nor in the RAC opinions were the uncertainties relating to both workers’ exposure and indirect exposure for human beings through releases of chromium trioxide into the environment qualified as ‘negligible’.

125. It also emerges from the above analysis that those uncertainties related to one of the key elements that must be considered in the analysis to determine whether the first condition of Article 60(4) of the REACH Regulation is met, namely the risk posed by the uses of the substance and the appropriateness and effectiveness of the risk management measures. In that regard, it should be noted that subparagraph (a) of that provision explicitly provides for that factor to be taken into consideration in the analysis to be carried out as part of the ‘socio-economic’ authorisation procedure.

126. It also emerges from the abovementioned RAC opinions – and is admitted, moreover, by the Commission itself in its pleadings – that some of the substantial uncertainties concerning exposure to chromium trioxide, and thus concerning the risk arising from the uses of that substance, were due not to the nature of the application itself, but rather to the approach chosen by the applicants. This related to the very broad scope of the application and the methodology chosen by them, which resulted in a considerable reduction in the quantity of data available for analysis. ( )

127. On that point, however, as noted in points 92 and 93, it is clear from the case-law that the burden of proving that the conditions laid down in Article 60(4) of the REACH Regulation are met rests on the applicant for authorisation and that it is that applicant who bears the risk of any impossibility of establishing whether a conclusion can be reached in relation to one or both of those conditions. That principle must apply a fortiori where the significant uncertainties concerning data required to carry out an appropriate scientific assessment remaining following analysis of the conditions laid down in that provision are the consequence of choices made by the applicant.

128. It should also be noted that the analysis of the contested decision and the RAC opinions carried out in points 107 to 121 above also shows that the assessment of worker exposure was based on measured data concerning a number of sites where the uses of chromium trioxide for which the authorisation was requested were performed or companies performing such uses that were in any event less than 3% of the total. An analysis based on such a limited quantity of factual data cannot, in my opinion, be considered to be based on a sufficient number of items of significant information, within the meaning of the case-law indicated in point 99 above. As can be inferred from point 121 above, the data provided by applicants concerning the exposure of ‘the majority’ of the population to the substance through inhalation also were not representative.

129. Furthermore, such a limited quantity of actual exposure data cannot, in my view, be considered as fulfilling the requirement arising from a combined reading of Article 62(4) of the REACH Regulation and point 5.2.4 of Annex I to that regulation, whereby the applicant for authorisation must provide ‘adequately measured, representative exposure data’ in order to allow the estimation of exposure levels for all human populations (workers, consumers and persons subject to indirect exposure via the environment).

130. Moreover, as can be seen from point 109 above, the Commission itself emphasised in the contested decision, as did RAC, the unrepresentative nature of the data provided concerning exposure, especially of workers, to chromium trioxide.

131. With regard to the argument raised by the Commission and ECHA that the analysis carried out by RAC was, however, also based on other data, such as those resulting from recent studies or from the modelled data provided in respect of use 2, I note that it is clear from RAC’s own opinions referred to above, and from the contested decision, that those additional data were not such as to eliminate the existence of significant uncertainties concerning exposure to the substance in question, in particular with regard to workers.

132. In that regard, recital 69 of the REACH Regulation clearly states that to ensure ‘a sufficiently high level of protection for human health … substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention’. Moreover, as can be seen from the preparatory work on the REACH Regulation, the authorisation regime for substances of very high concern was intended, inter alia, to solve the problems associated with the lack of data on exposure to those substances, particularly with regard to downstream users, which helps to explain why the burden of proof to provide such data was placed on the applicant for authorisation. ( )

133. In that context, an approach that makes it possible to authorise uses of a substance of very high concern on the basis of a very limited quantity of actual and specific data that are confirmed by data of a generic nature, which are unable to dispel the significant uncertainties remaining appears, to my mind, to be manifestly contrary to the need to treat such types of substances with careful attention. To accept that an individual can apply for an authorisation for the use of such a substance by providing only a very limited quantity of actual and specific data on the situation at the sites where that substance is used in my view clearly flies in the face of the logic of the system created by the REACH Regulation.

134. Moreover, the requirements relating to the burden of proof cannot depend on the scope of the application for authorisation, in the sense that they can be regarded as less stringent where the application relates to a large number of uses and therefore of sites and undertakings potentially affected by those uses. It is for that reason that, in my view, the Court must reject the Commission’s argument that it would not have been proportionate to require applicants to provide measured data from more than 1 500 downstream user sites for all uses covered by the application. It was not necessary for the applicants to provide data concerning all downstream user sites, but it was necessary to provide representative data and sufficient substantive information to allow the scientific analysis to be based on real data that adequately represented, not in abstract terms, the reality of exposure, especially of workers, to the substance of very high concern.

135. Certainly, as the Commission noted in its arguments on the second branch of the single plea in law, ( ) the possibility for upstream actors to apply for the whole supply chain (‘upstream applications’) streamlines the authorisation system and makes it function more efficiently. However, that streamlining cannot be implemented at the expense of rigorous analysis of the effects on human health of exposure to substances of very high concern. Even for these types of applications for authorisation, in line with case-law, the information on which the analysis is based must be substantive, reliable and numerically sufficient, and any remaining uncertainties must be classifiable as negligible if the authorisation is to be granted.

136. However, as explicitly stated in the contested decision and the RAC opinion, this was manifestly not the situation in the present case due to the limited data concerning actual exposure to the substance of very high concern, the wide variability of sites and operations handling the substance, and the lack of a sufficiently clear linkage between operational conditions, risk management measures and exposure values for specific tasks and specific sites.

137. As to the Commission’s argument, mentioned in point 55 above, that the contested decision would in any case contribute to protecting workers as it would reduce their exposure to chromium trioxide compared to the levels permitted under current legislation, I consider that statement irrelevant. Article 60(4) of the REACH Regulation does not in any way provide that the authorisation of use of a substance of very high concern is dependent on whether the authorisation decision results in a reduction of exposure to the substance as compared to the existing legislation.

138. As to the argument that the Parliament did not take into consideration the SEAC opinion, I note, first of all, that the Commission has not provided any precise reference to substantiate its claim that SEAC had explained why the data assessed by RAC were sufficient. In any event, given the significant uncertainties described in the preceding points and acknowledged by the Commission and RAC, an assessment of the risk arising from exposure to the substance, such as that in the present case, an assessment which then constitutes the basis for a balanced weighing of risks and benefits as required by Article 60(4) of the REACH Regulation in the context of the ‘socio-economic’ authorisation procedure, cannot be considered compatible with the requirements expressed by the case-law in points 99 and 100 above.

139. The Parliament further argues that it was specifically in order to remedy those uncertainties and deficiencies that Article 2(2) of the contested decision made the authorisation conditional upon the provision in the review report of the core data that were missing in the risk assessment in question.

140. In that regard, it should be noted that Article 2 of the contested decision lays down a number of obligations for authorisation holders and downstream users. In accordance with that article, authorisation holders must develop specific exposure scenarios (Article 2(2)), they must make the specific exposure scenarios available to downstream users, who are required to apply them (Article 2(3)), and they must verify and validate those scenarios on the basis of an analysis of data concerning actual exposure and measured emissions of the substance which are made available to those holders by downstream users (Article 2(4)). Authorisation holders and downstream users must then implement monitoring programmes that are representative of operational conditions and risk management measures (Article 2(6)). Downstream users must then make the information gathered through such monitoring programmes available to ECHA and authorisation holders for the purpose of verifying and validating the exposure scenarios (Article 2(9)).

141. In that situation, although there is nothing to preclude conditions being imposed to obtain a more detailed representation over time of the processes associated with use of the substance of very high concern by means of data from authorisation holders in cooperation with their downstream users, it is nonetheless explicitly stated in recital 12 of the contested decision that in its opinions on uses 1, 2, 4 and 5, RAC recommended that additional conditions and monitoring arrangements be imposed ‘due to the uncertainties in the assessment of risks to workers and to the general population via the environment’.

142. It is clear, however, from the case-law cited in points 100 to 102 above, that the conditions imposed under Article 60(8) and (9)(d) and (e) of the REACH Regulation cannot be imposed in order to remedy any deficiencies in an application for authorisation or substantial uncertainties in the examination of the conditions laid down in Article 60(4) of the REACH Regulation, which, conversely, does appear explicitly to be the case with the contested decision in the present case.

143. On the basis of all of the above considerations, it is my view that the first branch of the single plea in law introduced by the Parliament must be upheld.

4. The second branch of the single plea in law, relating to the failure to ascertain that no suitable alternative substances or technologies were available for uses 2, 4 and 5

144. In the second branch of its single plea in law, the Parliament asserts that the Commission failed to ascertain that no suitable alternative substances and technologies were available before granting the authorisation for uses 2, 4 and 5 for chromium trioxide, as required by Article 60(4) of the REACH Regulation, and that, therefore, the contested decision was adopted in breach of that provision.

145. In that regard, it should be noted that, in the context of a ‘socio-economic procedure’, the second condition required under Article 60(4) of the REACH Regulation establishes that the authorisation for use of the substance of very high concern may only be granted if there are no suitable alternative substances or technologies.

146. According to recital 12 and Article 55 of the REACH Regulation, one of the main objectives of the new system to be established by that regulation was to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.

147. Furthermore, it is clear from the case-law that Article 60(4) of the REACH Regulation does not allow the Commission to authorise the use of a substance of very high concern if another suitable substance can be substituted for it. Consequently, the Commission cannot grant such authorisation before having duly ascertained that there is no available alternative. ( )

148. In order to be able to examine the arguments put forward by the parties in that regard, it is, in my view, necessary first to analyse in detail the approach adopted by the Commission with regard to the second condition laid down in Article 60(4) of the REACH Regulation, as seen from the contested decision read in the light both of the SEAC opinion and of the explanations provided by the Commission itself and by ECHA in their pleadings.

(a) The approach applied by the Commission in the contested decision

149. The contested decision shows that based on its analysis, taking into consideration the SEAC opinion, the Commission was able to conclude that the applicants had demonstrated horizontally and generally that there were no suitable alternatives for uses 2, 4 and 5 as defined in the application for authorisation with regard to all identified sectors. ( )

150. However, in view of the very broad scope of the uses for which authorisation had been sought, the Commission, in line with SEAC’s findings in its opinion, also considered that the applicants had not demonstrated that there were no suitable alternatives for each possible downstream use that might possibly exist in those different sectors. ( )

151. In that context, in order to ensure that the authorisation covered only those uses for which no suitable alternatives were available, the Commission deemed it ‘necessary to further specify the description of uses 2, 4 and 5’, as indicated by the applicants in their application. The Commission made that specification of the description of the uses in question by referring to certain ‘key functionalities’, which it identified, that would be necessary for the intended use.

152. As explained by ECHA in its statement in intervention, those key functionalities, identified in recital 20 of the contested decision and described in footnote 14 above, are objective criteria, such as corrosion resistance, hardness, humidity and heat resistance, food safety, etc., which delimit the scope of the authorised use.

153. Using that approach, the Commission granted authorisation in Article 1(1) of the contested decision for uses 2, 4 and 5 only where one of the key functionalities indicated in that decision was necessary for the intended use. In paragraphs 2, 3 and 4 of the same article, the Commission refused authorisation where none of the key functionalities listed in paragraph 1 was necessary for the intended use.

154. It therefore appears from the contested decision, read in the light of the information in the file, that if, for example, corrosion resistance (a key functionality identified for use 4) is required for a surface treatment operation for an application in the aeronautical industry (use 4), then the use of chromium trioxide falls within the scope of the authorisation granted for that use. If, conversely, none of the key functionalities set out in the contested decision for use 4 is necessary for an operation covered by that use, then the use of chromium trioxide falls outside the scope of the authorisation granted in the contested decision for that use.

155. Furthermore, the Commission considered that in order to facilitate the enforcement of the decision, with regard to uses 2, 4 and 5, it was necessary to require the authorisation holders’ downstream users to include, in the notification sent to ECHA, an explanation of the key functionalities listed in the contested decision which are necessary for their use, including a justification as to why they are necessary for that use. ( ) To that end, Article 5 of the contested decision establishes an obligation for downstream users to provide ECHA with an explanation of the key functionalities of chromium trioxide necessary for their use, including a justification why such key functionalities are necessary for that use.

156. The Parliament is challenging both the Commission’s analysis of the conclusion regarding the absence of suitable alternatives within the meaning of Article 60(4) of the REACH Regulation and the use of the notion of ‘key functionalities’ to dispel uncertainties about the existence of suitable alternative substances or technologies. The Parliament also considers that the requirement for downstream users to provide information is in fact intended to remedy the shortcomings of the analysis as to the existence of alternative solutions. The Commission and ECHA, on the other hand, defend the approach taken in the contested decision.

157. In this context, I consider that, essentially, two issues must be analysed in concrete terms: (i) the analysis carried out by the Commission must be assessed, in the light of the SEAC opinion as to whether there are suitable alternative substances or technologies within the meaning of the abovementioned provision, and (ii) the Court needs to assess the methodology used by the Commission to dispel existing doubts about the existence of suitable alternatives, aimed at specifying the scope of the uses for which authorisation had been requested by the applicants, and thus limiting the authorisation by reference to key functionalities in connection with the information obligation imposed on downstream users.

(b) The analysis as to whether suitable alternative substances or technologies exist

158. With regard first to the analysis carried out by the Commission to determine whether suitable alternatives exist, as already mentioned, the Commission stated in recital 18 of the contested decision that ‘in its opinions on uses 2, 4 and 5, SEAC concluded that there are no suitable alternative substances or technologies’ but that ‘due to the very broad scope of the uses applied for, SEAC could not exclude possible uncertainty with regard to the technical feasibility of alternatives for a limited number of specific applications that are covered by the description of those uses’.

159. In my view, the first question that arises here is whether, in the context of a ‘socio-economic’ procedure, in the case of an ‘upstream application’ such as that in the present case – that is to say in the case of an application for authorisation submitted by upstream actors for the use of a substance of very high concern throughout the entire supply chain, an application which generally presupposes a potentially very broad description of uses – for the second requirement laid down by Article 60(4) of the REACH Regulation to be considered to be met, it is sufficient for applicants to demonstrate generally and horizontally that there are no suitable alternatives for the uses as defined in the application for authorisation in respect of all the identified sectors, or whether it is necessary for the Commission to determine that there are no suitable alternatives for the individual downstream uses of the substance existing in those different sectors in order for authorisation to be granted.

160. In that regard, I consider that a lenient interpretation of the second requirement of Article 60(4) of the REACH Regulation which, in the case of an ‘upstream application’, allows applicants to discharge their burden of proof by merely demonstrating, generally and horizontally, that there are no suitable alternatives for the uses as defined in the application for authorisation without requiring a rigorous analysis as to whether there are alternatives for downstream uses, would be incompatible with the spirit and objectives of the REACH Regulation.

161. First, by not requiring a rigorous analysis of the existence of suitable alternatives to the use of the substance for its downstream uses, such an interpretation would go against one of the main objectives of the REACH Regulation, as mentioned in recital 12, taken up in point 146 above and in Article 55 of that regulation, namely to encourage and in certain cases to ensure that substances of very high concern are replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives to the use of the substance are available.

162. Second, as already noted in point 135 above, the streamlining resulting from ‘upstream applications’ for authorisation, although desirable, cannot be carried out at the expense of the rigour of the analysis applied for authorisation of substances of very high concern. In my opinion, it is not therefore possible to interpret the second requirement of Article 60(4) of the REACH Regulation in a lenient manner, thus reducing the rigour of the analysis, because of the possible practical difficulties in meeting that requirement arising from the very broad scope of the uses for which authorisation is sought. It should be recalled that the REACH Regulation is based on the precautionary principle, which assumes a maximum degree of rigour in the analysis of the risk to health and the environment arising, in particular, from the use of substances of very high concern. As stated in recital 69 of the REACH Regulation, such substances ‘should, in accordance with the precautionary principle, be subject to careful attention’.

163. I therefore agree with the Parliament that the fact that the range of uses in the application is so broad as to require a multitude of assessments of the availability of alternative solutions in each individual context cannot justify a less rigorous approach when assessing the availability of alternatives, as that would run counter to the main objective of the REACH Regulation, which is to protect human health and the environment.

164. In the light of those considerations, I take the view that the provision in Article 60(4) of the REACH Regulation must be interpreted as meaning that the Commission is required to ascertain whether the use for which an authorisation is sought includes different uses, which must be defined on the basis of the technical performance required, and is required to determine whether there are alternatives for each of those uses.

165. Thus, if there are uses of the substance within the framework of the uses as generally defined by the applicants, possibly carried out by downstream users, for which suitable alternatives exist, those uses may not fall within the scope of the authorisation granted for the use.

166. That does not mean that the Commission must – as it argued – carry out a separate assessment of alternative solutions for each downstream user or product, which might require an unreasonable number of separate assessments, depending on the degree of specificity. However, the Commission is required to determine that there are no suitable alternative substances or technologies for the full scope of uses for which authorisation is sought by considering all potential downstream uses of that substance.

167. Having thus determined the scope of the second requirement laid down in Article 60(4) of the REACH Regulation, it must be ascertained whether, in the present case, the analysis carried out by the Commission complies with that provision.

168. In that regard, to understand better the scope of the relevant recitals of the contested decision, and in particular recital 18, reference should be made to SEAC’s opinions on uses 2, 4 and 5. In the present case SEAC stated the following in those opinions:

‘The applicant has made an extensive assessment of alternatives, especially when it comes to the aspect of technical feasibility.

…

Nevertheless, due to the extremely broad scope of this use applied for, SEAC cannot exclude that there are indeed a limited number of applications where substitution is already feasible or will become so at short-term. In fact, it is not clear to SEAC when alternatives will eventually become available for specific applications. Ideally, SEAC would have been provided with an exhaustive list of all the applications/components covered by the use [in question] in order to judge the actual feasibility/infeasibility of alternatives and to ensure that substitution takes place where already feasible. However, SEAC recognises that this is hardly possible for applicat