Background

1. In September 2022, the Ombudsman organised a public consultation on transparency and participation in EU environmental decision-making.[1] One of the issues brought to the Ombudsman’s attention concerned delays and limited transparency in the risk management of dangerous chemical substances by the European Commission.[2]

2. The use of chemical substances in the EU is governed by the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (the ‘REACH Regulation’).[3] The REACH Regulation was designed to protect human health and the environment from the risks that can be posed by chemicals, by shifting the burden of proof from regulators to industry. It obliges companies to generate information on the chemicals they produce or import to the EU, in line with the principle of ‘no data, no market’.[4]

3. Based on this information, the Commission can decide, among others, to restrict the use of certain particularly dangerous substances or subject their use to prior authorisation. Such particularly dangerous substances, referred to as ‘substances of very high concern’, may be carcinogenic, mutagenic, toxic for reproduction, or have endocrine disrupting properties. They may also be persistent, bioaccumulative and toxic. The designation of a substance as a ‘substance of very high concern’ is a result of a procedure involving a thorough scientific assessment and, in case there are divergent opinions, requires a unanimous agreement of the members of European Chemicals Agency’s (ECHA) ‘Member State Committee’.[5] Subsequently, the Commission may include ‘substances of very high concern’ on the list of substances the use of which is subject to prior authorisation.[6]

4. Companies that wish to use substances from this list must submit applications for authorisation to the Commission. In their authorisation applications, companies must demonstrate either that the risks to public health and the environment resulting from the use of the relevant substance are adequately controlled (the ‘adequate control route’)[7] or that the socio-economic benefits of its continuous use outweigh the risks and that there are no suitable alternative substances or technologies available (the ‘socio-economic route’).[8]

5. Two expert committees of ECHA, composed of independent experts,[9] provide the Commission with scientific and technical advice as to whether an application fulfils the conditions for authorisation: the Risk Assessment Committee (RAC) and the Socio-Economic Assessment Committee (SEAC). Based on that advice, the Commission presents a draft decision on the application for authorisation to the ‘REACH Committee’,[10] which is composed of Member State representatives. The REACH Committee must approve the draft decision before the Commission can adopt it.

6. A company that submits an application for the authorisation of a substance from the above list (see paragraphe 3, above) within a deadline specified in the REACH Regulation may continue to use this substance as long as the authorisation decision-making process is ongoing. During this time, additional conditions and monitoring arrangements that the Commission may define in its authorisation decision are not yet applicable. Moreover, the Commission may ultimately refuse to grant the authorisation, having concluded that the legal conditions have not been met.

7. In reply to the Ombudsman’s public consultation, concerns were brought to her attention about the time that it takes the Commission to complete the risk management processes under the REACH Regulation. Concerns were also expressed that there is insufficient information in the public domain that would allow the public to understand the causes of the delays.

8. The Ombudsman had already called in one of her previous inquiries[11] on the Commission to demonstrate “a greater sense of urgency” and to complete its decision-making processes concerning the risk management of dangerous chemicals more rapidly. To achieve the fundamental goals of the REACH Regulation, that is, to protect human health and the environment from chemical substances, it is in the public interest that this regulation be implemented in full and in a timely way.

9. Against this background, the Ombudsman decided to open an own-initiative inquiry to examine the delays in the Commission’s procedure for granting or refusing authorisations under the REACH Regulation and the transparency of that procedure.

Inquiry

10. The Ombudsman first asked the Commission to provide statistical data regarding the time it takes to complete the authorisation procedure.[12] The Ombudsman also asked the Commission for information on the process it follows when deciding on authorisation applications and what information it makes proactively available concerning that process, including in the ‘Comitology Register’[13].

11. The Ombudsman inquiry team held two meetings with representatives of the Commission to discuss these issues.[14]

12.  The Ombudsman inquiry team also inspected the files concerning a sample of 12 applications for authorisation submitted to the Commission.[15]

13. On 17 October 2024, the Ombudsman issued a recommendation in this case.[16]

14. On 30 January 2025, the Commission replied to the Ombudsman’s recommendation.[17]

The Ombudsman’s recommendation

15. In her recommendation, the Ombudsman took the view that the Commission must demonstrate an appropriate sense of urgency in examining applications for authorisation of a ‘substance of very high concern’, given that a company that submits an application for authorisation can usually continue to use the substance as long as the decision-making process is ongoing.[18] The Commission should do its utmost to avoid situations in which companies use ‘substances of very high concern’ although it is not certain whether they meet the legal conditions under the REACH Regulation.

16. The Ombudsman found that the Commission incurred significant delays in drafting decisions on applications for authorisation. While the REACH Regulation sets a time limit of three months for the Commission to prepare a draft decision granting or refusing authorisation,^[19] after receiving the opinions of RAC and SEAC, it takes the Commission on average 14.5 months to do so in practice. Subsequently, the discussions within the REACH Committee take further months or even years before the decision on the authorisation is taken.

17. The Commission sought to justify non-compliance with the statutory time-limit of three months by reference to its internal organisation, the significant increase in applications, the complexity and uncertainty of information contained in the applications, as well as the time needed to verify the consistency of RAC and SEAC opinions and to take a broader view on them. The Commission mentioned frequent divergences between Member State representatives in the REACH Committee as a further element adding to the time it takes to complete the authorisation procedure.

18. The Ombudsman was not convinced by the Commission’s position that it could not comply with the statutory time limit of three months to draft a decision after receiving the opinions of RAC and SEAC.

19.  First, the Ombudsman considered that the Commission’s internal organisation - including two Commission departments with joint responsibility for drafting decisions and well established internal consultation procedures - cannot justify non-compliance with statutory time-limits.

20. Second, the Ombudsman observed that recent case law on the burden of proof in the authorisation procedure clarifies how the Commission should deal with uncertainties in the information provided by applicants. The EU Courts recently annulled decisions in which the Commission granted authorisations to use certain substances despite insufficient information regarding the level of risk posed by these substances and the existence of alternative solutions.[20] According to this case law, the burden of proof regarding compliance with the legal conditions for authorisation rests on the applicants.[21]

21. In the Ombudsman’s view, the Commission should ensure that applications containing insufficient information are promptly dismissed, so that the companies that have submitted those applications can no longer use the dangerous substances in the EU.

22. This is even more important where the Commission is faced with a significant number of applications. In this context, the Ombudsman was concerned that the initial check by RAC and SEAC of information provided in the applications consists only of verifying, in the Commission’s words, whether “all the boxes have been ticked”, whereas the REACH Regulation requires the committees to verify that “the application includes all the information” relevant to the assessment.[22] The Ombudsman observed that it cannot be ruled out that some applicants exploit the possibility to continue to use dangerous substances by submitting incomplete applications. Based on the inspection of a sample of authorisation files, the Ombudsman was concerned that serious doubts as to whether the applicants have discharged their burden of proof dragged on rather than being resolved at the outset. The Ombudsman observed that the Commission could consider asking RAC and SEAC to flag to it any applications containing insufficient information at an early stage, so as to allow the Commission to dismiss these applications promptly.

23. Third, the Ombudsman noted that, in drafting authorisation decisions, the Commission relies on the opinions of RAC and SEAC, which are in principle sufficient to inform the Commission’s draft decision. This was confirmed by the Commission’s internal guidelines for drafting the decisions by its two departments, which the Commission shared with the Ombudsman. According to these guidelines, the two departments should in principle follow the opinions of RAC and SEAC. The case law says that the Commission cannot depart from these opinions unless it obtains a “supplementary opinion from the same committee or other evidence, whose probative value is at least commensurate with that of the opinion concerned”.[23] The Ombudsman understood, based on the Commission’s explanations, that the Commission has not yet made use of this possibility to base its draft decisions on “other evidence”. In this context, it is hard to see how there can be systemic disagreements between the Commission departments lasting for months, let alone years.

24. In view of the above, the Ombudsman found that the systemic failure by the Commission to comply with the statutory three-month time limit to present draft decisions to the REACH Committee constituted maladministration.

25. The Ombudsman recommended that the Commission should:

• (i) review its internal procedures,
• (ii) apply the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the authorisation by providing sufficient information,
• (iii) ensure that applications containing insufficient information are promptly dismissed, so that the companies that have submitted those applications can no longer use the dangerous substances in the EU.

26. As regards the transparency of the REACH Committee’s proceedings, the Ombudsman considered that the public must be in a position to scrutinise the causes of the delays in the authorisation procedure and to hold the relevant actors to account, not only the Commission, but also the Member State representatives in the REACH Committee. She reminded the Commission that the documents produced in the context of the authorisation process under the REACH Regulation should benefit from the wider public access granted to documents containing environmental information[24] and that any confidentiality arrangements contained in the rules of procedure of the ‘comitology’ committees do not prevail over the EU legislation on public access to documents,[25] as confirmed by the EU Courts.[26]

27. The Ombudsman found that the Commission does not currently publish information which would allow the public to understand the causes of the excessive timeframes in the authorisation procedure, including when these are due to disagreements among the actors involved. In particular, the summary records of REACH Committee meetings do not capture the state of play of individual files and the reasons for possible delays. This prevents the public from holding those responsible for delays to account. The Ombudsman found that this constituted maladministration and she made a corresponding recommendation that the Commission publish more substantial summary records of the REACH Committee meetings.

The Commission’s opinion

28. In its opinion on the Ombudsman’s recommendation, the Commission confirmed its commitment to transparency and agreed to provide more substantial summary records of REACH Committee meetings.

29. The Commission also acknowledged the delays in the authorisation procedure.

30. However, the Commission disagreed with the Ombudsman’s analysis of the main causes that have led to the delays. In particular, the Commission disagreed that one of these causes is how it has applied the burden of proof and the “leniency by the Commission towards applicants, so as to avoid refusing authorisations when applications are incomplete, or when the applicant has not discharged its burden of proof.” According to the Commission, “this does not correspond to the practice implemented so far”. The Commission said that “it no longer includes measures intended to remedy key shortcomings of applications for authorisation (i.e. affecting conditions for granting an authorisation) that should have instead led to a refusal of the authorisation. The Commission has tightened its approach accordingly after that case law... As regards new cases, the Commission is no longer introducing such measures, e.g. remedying a flawed risk assessment or analysis of alternatives”.

31. As regards its understanding of the main causes of the delays, the Commission emphasised, first, a “huge influx of applications” which has been “unexpected and, neither ECHA, nor the Commission, have the capacity to deal with it, which has led to unwanted delays and backlog”, in particular due to “the inclusion in the authorisation list of substances with wide-spread uses covering many industrial sectors”. In this context, the Commission said that it needs more time to verify the robustness and completeness of RAC and SEAC opinions to ensure the consistency of its decisions and the equal treatment of applicants.

32. The Commission also argued that it cannot dismiss more applications to alleviate the delays because, in almost all the applications processed so far, the opinions of RAC and SEAC have been positive. The Commission is concerned that a refusal in such cases would end up in legal challenges. In addition, the Commission provided examples of recent cases in which it proposed refusals to the REACH Committee, to show the Commission’s readiness to enforce the burden of proof.[27]

33. Second, the Commission argued that the recent case law contributed to the delays because its implementation required a thorough analysis and discussion among the Commission’s departments and members of the REACH Committee, including an in-depth reassessment of all pending applications. Also, the Commission had to give an opportunity to some applicants to provide missing elements in their applications, which turned out to be incomplete in light of the new case law.

34. Third, according to the Commission, preliminary discussions with members of the REACH Committee may significantly add to the delays. The Commission said that “positioning of Member States and likelihood of support by a qualified majority are key elements taken into account by the Commission in identifying specific measures/provisions in the decisions before presenting new drafts”.

35. In general, the Commission considered that the authorisation system under the REACH Regulation has proven to be too burdensome to efficiently and effectively achieve its intended objectives, especially for substances with wide uses. The Commission considered that restricting the use of substances may be less burdensome than adding ‘substances of very high concern’ to the list of substances subject to authorisation, because restrictions apply without the need for companies to submit applications for authorisations or further derogations. The Commission said that it is now more cautious in adding new substances to the list of substances subject to authorisation.

The Ombudsman's assessment after the recommendation

36. The Ombudsman is very concerned about the delays in the authorisation procedure under the REACH Regulation, which her inquiry brought to light.

37. What these delays mean is that particularly dangerous chemical substances may continue to be available on the EU market even though it may turn out that authorisation should not be granted at all, or that it should be granted under specific conditions and monitoring arrangements only.

38. These delays therefore constitute a serious risk to public health and the environment.

39. They may also undermine the interests of companies whose economic activities may be disrupted due to persisting uncertainty as to whether an authorisation will be granted or not. Faced with these challenges, the Commission should do its utmost to present a clear plan of how to address the delays.

40. With her recommendation, the Ombudsman urged the Commission to address the delays as a matter of priority. Specifically, the Ombudsman asked the Commission to review its lengthy internal procedures and to examine any shortcomings in enforcing the burden of proof.

41. While the Commission acknowledged in its opinion the delays in the authorisation procedure, it disagreed with the Ombudsman as to their causes. In particular, the Commission insisted that the actual causes of the delays lay beyond its control, and mentioned in this regard the sheer number of applications, their complexity, the need to implement the court judgments on the burden of proof, and lengthy discussions due to divergences in positions among members of the REACH Committee.

42. Whatever the merits of the Commission’s above mentioned explanations, the Ombudsman believes that the Commission should have engaged more meaningfully with her recommendations. In particular, the Commission in its opinion:

• did not address the Ombudsman’s recommendation to review its lengthy internal procedures, in particular how it has allocated responsibilities to its departments;
• provided inconsistent and incomplete information on its practice of enforcing the burden of proof when assessing applications for authorisation, and  
• did not present a clear and comprehensive plan on how to address the challenge of delays in the authorisation procedure.

I. Review of internal procedures

43. First, the Commission did not at all address the shortcomings in its internal procedures for drafting authorisation decisions. While it is not the Ombudsman’s role to tell the Commission how exactly to organise its internal procedures, she reiterates her view that the internal organisation of the Commission cannot justify non-compliance with strict time limits laid down by law.

II. Practice of enforcing the burden of proof

44. Second, as regards the Commission’s practice of enforcing the burden of proof in the assessment of applications for authorisation, the Commission argued, on the one hand, that it has not been too “lenient” towards applicants with regard to the burden of proof. On the other hand, it acknowledged that it “no longer” seeks to “remedy key shortcomings of applications... affecting conditions for granting an authorisation... that should have instead led to a refusal of the authorisation”. Moreover, the Commission said that the recent case law on the burden of proof has triggered substantial changes in its practice, including the need to reassess all pending applications and to request additional information from some applicants. According to the Commission, the implementation of this case law substantially added to the delays. At the same time, the Commission said that the Ombudsman’s recommendation regarding the burden of proof “relate[s], to a certain extent, to practices/approaches that are already implemented by the Commission”.

45. While the Commission acknowledged that it had changed its practice of enforcing the burden of proof, it remains unclear to what extent it considers that its past practice had contributed to the delays and, if so, how its new approach is expected to reduce them.

46. In this context, the Commission also seems to disagree with the Ombudsman’s recommendation to ensure that applications containing insufficient information are to be dismissed promptly in order to reduce the overall delays. The Commission appears to be particularly concerned about legal challenges to its decisions by companies to whom authorisations may be denied despite positive conclusions of RAC and SEAC. The Commission remarked, in this context, that RAC and SEAC usually present positive conclusions on the applications.

47. In that regard, the Ombudsman notes that the Commission is not bound by the conclusions of RAC and SEAC.^[28] Rather, the Commission must consider the entire body of information reported in RAC and SEAC opinions. This includes any information provided by Member States or third parties,[29] and in particular any uncertainties highlighted by RAC and SEAC^[30] or contradictions in the available information.^[31] In fact, the EU Courts have recently annulled the Commission’s authorisation decisions that followed RAC and SEAC (positive) conclusions without sufficiently taking into account uncertainties reported in their opinions.^[32] If there are issues with the clarity and consistency of RAC and SEAC opinions, as signalled by the Commission,^[33] the Commission should undertake systemic measures to address these issues with ECHA.

III. Commission’s response to the delays in the authorisation procedure

48. The Commission failed to present in its opinion a clear and comprehensive plan on how to address the challenge of delays in the authorisation procedure.

49. As mentioned above, the Commission focused its opinion on justifying why the authorisation procedure has proven to be too burdensome due to factors beyond its control, referring in particular to the significant increase in applications, their complexity, the need to implement the court judgments on the burden of proof and lengthy discussions due to divergences in positions among members of the REACH Committee.

50. The Ombudsman notes that the Commission had already raised these factors in its written replies and during meetings with the Ombudsman inquiry team. She does not dispute that these factors may have contributed to the delays in the Commission’s drafting of authorisation decisions in the past. However, the Ombudsman maintains the view expressed in her recommendation that these factors cannot justify the delays.[34]

51. As regards in particular the divergences in positions among members of the REACH Committee, the Ombudsman wishes to add that the Commission’s role is to draft an authorisation decision based on all the elements provided by ECHA’s committees RAC and SEAC. Subsequently, it is the REACH Committee’s role to discuss and vote on the Commission’s draft decision. This process should be carried out in a fully transparent manner for citizens to be able to hold the Commission and their national representatives in the REACH Committee to account.

52. While the Ombudsman welcomes that the Commission accepted her recommendation to publish more substantial summary records of the meetings of the REACH Committee, she is concerned about the Commission’s practice of seeking preliminary views of Member States on specific files before finalising its draft decisions. In its opinion, the Commission said that Member States’ preliminary positions and the resulting likelihood of obtaining support are key elements in the Commission’s process of drafting decisions. However, in the context of complying with clear and strict statutory time limits imposed by the REACH regulation, this practice, on balance, may actually contribute to the delays in the drafting process, while rendering at the same time the whole process less transparent.

53. Thus, the Ombudsman’s view is that preliminary discussions with members of the REACH Committee should not prejudice the Commission’s main task of assessing the applications in an objective and impartial manner, based on RAC and SEAC opinions, while observing the strict statutory time limit of three months.

54. If at the end of this process some Member States refuse to approve a draft decision prepared by the Commission, EU citizens should be fully informed about this and thus enabled to scrutinise the conduct of their representatives and hold them to account.

55. As a response to the delays in the authorisation procedure, the Commission informed the Ombudsman that it is increasingly opting for restrictions rather than subjecting substances to prior authorisation. The Commission also referred to the upcoming revision of the REACH Regulation. The Ombudsman considers that the effects of these measures are too uncertain at this stage to constitute a satisfactory response to the challenges that the Commission is now facing.

56. The Ombudsman recalls that the list of substances subject to prior authorisation plays an important role in the risk management of chemicals in the EU established by the REACH Regulation. Therefore, the Commission should not try to avoid adding new substances to this list for reasons of administrative efficiency or expediency.

57. As regards the future amendment of the REACH Regulation, until and unless such amendment takes place, the Commission should not give the impression that it seeks to extend the current strict statutory time limits to present a draft decision to the REACH Committee in anticipation of future changes regarding its internal decision-making process. As the law stands to date, a timely decision-making process on risks stemming from dangerous chemicals is crucial for the protection of public health and the environment. Based on her inquiry, the Ombudsman considers that the current statutory deadline of three months for drafting decisions is feasible, given that the Commission’s draft decisions are based on comprehensive opinions of ECHA’s RAC and SEAC committees.

58. In view of the above, the Ombudsman maintains her finding of maladministration.

59.  None of the arguments raised by the Commission in its opinion can be relied upon to justify the serious delays in the authorisation procedure under the REACH Regulation. While the Commission disagreed with the Ombudsman’s analysis of the causes of the delays, it did not provide a meaningful and consistent opinion on all aspects of the Ombudsman’s recommendation, including not coming up with a clear and comprehensive plan on how to address the challenge of delays in the authorisation procedure.

Conclusions

Based on the inquiry, the Ombudsman closes this case with the following conclusions:

The Commission accepted the Ombudsman’s recommendation to publish more substantial summary records of the REACH Committee meetings.

The Commission partly accepted the Ombudsman’s recommendation to apply the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the authorisation to use a particularly dangerous chemical substance. At the same time, the Commission did not accept the Ombudsman’s recommendation to ensure that applications containing insufficient information are promptly dismissed.

The Commission did not address the Ombudsman’s recommendation to review its internal procedure for handling the applications for authorisation.

The Ombudsman considers that the Commission did not present a clear and comprehensive plan of how to address the challenge of the delays, including a review of its own role within the REACH Committee. Therefore, the Ombudsman maintains the finding of maladministration concerning the Commission’s systemic failure to comply with the statutory three-month time limit to present draft decisions to the REACH Committee.

The Commission will be informed of this decision.

Teresa Anjinho
European Ombudsman

Strasbourg, 27/06/2025

 

[1] https://www.ombudsman.europa.eu/en/public-consultation/en/160313

[2] The reply to question no 5 in https://www.ombudsman.europa.eu/en/doc/correspondence/en/169594.

[3] Regulation 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 396/1, consolidated text at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20140410.

[4] Article 5 of the REACH Regulation.

[5] Article 59 of the REACH Regulation.

[6] Article 58 of the REACH Regulation.

[7] Article 60(2) of the REACH Regulation.

[8] Article 60(4) of the REACH Regulation.

[9] Article 85(7) of the REACH Regulation.

[10] Article 64(8) and 133(3) of the REACH Regulation.

[11] Decision of the European Ombudsman closing own-initiative inquiry OI/2/2016/RH concerning delays by the

European Commission in processing files on the reproductive toxicity of chemical substances, paragraph 27,

https://www.ombudsman.europa.eu/en/decision/en/81645.

[12] See the written replies of the Commission: https://www.ombudsman.europa.eu/en/doc/correspondence/en/174970 and https://www.ombudsman.europa.eu/en/doc/correspondence/en/189320.

[13] https://ec.europa.eu/transparency/comitology-register/screen/committees/C34200/consult?lang=en.

[14] See reports from these meetings: https://www.ombudsman.europa.eu/en/doc/inspection-report/en/178826 and https://www.ombudsman.europa.eu/en/doc/inspection-report/en/191331.

[15] See the request for inspection (Annex 1), https://www.ombudsman.europa.eu/en/doc/correspondence/en/178825.

[16] Recommendation on the risk management of dangerous chemical substances by the European Commission (case OI/2/2023/MIK), https://www.ombudsman.europa.eu/en/recommendation/en/194088.

[17] https://www.ombudsman.europa.eu/en/doc/correspondence/en/199074.

[18] Article 58(1)(c)(ii) of the REACH Regulation. The deadline for submitting an application to rely on the right of continuous use is 18 months before the so-called ‘sunset date’, from which the placing on the market and the use of the substance is prohibited.

[19] Article 64(8) of the REACH Regulation.

[20] Judgment of 7 March 2019, Case T-837/16, Sweden v Commission, https://curia.europa.eu/juris/document/document.jsf;jsessionid=7294BECA711A439D8C6681EA7E8E8E49?text=&docid=211428&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=1396235, as upheld by judgment of 25 February 2021, Case C-389/19 P, https://curia.europa.eu/juris/document/document.jsf?text=&docid=238162&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=14037038; and judgment of 20 April 2023, Case C-144/21, Parliament v Commission, https://curia.europa.eu/juris/document/document.jsf;jsessionid=88F010BC9D2D47DC02B61F64F40F6FD4?text=&docid=272682&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=2524212.

[21] Case T-837/16, Sweden v Commission, paragraph 79; Case C-144/21, Parliament v Commission, paragraph 46.

[22] Article 64(3) of the REACH Regulation.

[23] Case T-837/16, Sweden v Commission, paragraph 69.

[24] Article 6 of Regulation 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies, OJ L 264/13, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1367.

[25] Recommendation of the European Ombudsman in case 2142/2018/TE on the European Commission’s refusal to grant access to Member State positions on a guidance document concerning the risk assessment of pesticides on bees, https://www.ombudsman.europa.eu/en/recommendation/en/113624.

[26] Judgment of 14 September 2022, Joined Cases T-371/20 and T-554/20, Pollinis France v Commission, paragraph 96, https://curia.europa.eu/juris/document/document.jsf?text=&docid=265442&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=13008442, as upheld by judgment of 16 January 2025, Case C-726/22 P, Commission v Pollinis, https://curia.europa.eu/juris/document/document.jsf?text=&docid=294251&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=13021830.

[27] The Commission mentioned in its opinion on the Ombudsman’s recommendation (page 3, footnote 5): “SD_Gruppo Colle, SD_Ormezzano, CTPhT_DEZA, CTPhT_Bilbaina, Lead sulfochromate yellow and Lead chromate molybdate sulphate red_DCC. Maastricht B.V., MOCA_REACHLaw. DEHP_Deza (the last two decisions were not adopted since the applicants withdrew the applications).”

[28] Case T-837/16, Sweden v Commission, paragraph 66.

[29] Case T-837/16, Sweden v Commission, paragraphs 12-15 and 92. Article 64(3) of the REACH Regulation stipulates that “each Committee shall also take into account any information submitted by third parties” within public consultation, as laid down in Article 62(2).

[30] Case C-144/21, Parliament v Commission, in particular paragraphs 62-68 and 85, and 107-110 and 124.

[31] Case T-837/16, Sweden v Commission, paragraph 85.

[32] Case T-837/16, Sweden v Commission, paragraphs 92-94; Case C-144/21, Parliament v Commission, paragraphs 71-85.

[33] The Commission argued that it must verify whether RAC and SEAC opinions are “full, consistent and relevant”. Case T-837/16, Sweden v Commission, paragraph 68.

[34] Recommendation on the risk management of dangerous chemical substances by the European Commission (case OI/2/2023/MIK), https://www.ombudsman.europa.eu/en/recommendation/en/194088, paragraphs. 26-40.